Phase 1 Trials
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Phase 1 Trials
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All Comers
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-NTMDT23238
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
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Inclusion Criteria:
1. Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider.
2. All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
3. Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
4. Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
- Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response [CR] or partial response [PR]) to any intervening therapy after collection of the tissue
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
5. Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
* NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only
*NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
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Specific Mutation
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VICCPHI2207
Ph1 of ASP3082 Pts w/Prev Tx Locally Adv or Metastatic Solid Tumor Malignancies w/KRAS G12D Mutation
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VICC-DTPHI23103
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. For Phase 1b: locally advanced, recurrent, or metastatic, incurable, and histologically or cytologically confirmed HR+/HER2- breast cancer by ASCO/CAP criteria (based on most recent assessment):
a) Must have received CDK4/6i in the adjuvant or metastatic setting, unless patient was unable or unwilling to receive standard of care CDK4/6i treatment; or must be able to receive it on protocol, AND,
b) Received no more than 1 prior line of therapy containing chemotherapy (including cytotoxic antibody-drug conjugates) given in the metastatic setting; AND,
c) Must have received no more than 3 lines of therapy in total for metastatic disease.
d) May have received a prior PI3Ka inhibitor
NOTE: If the patient progressed on the PI3K inhibitor a sample (tissue or liquid) must have been obtained following progression, or at study screening, to be analyzed at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory, determine the resistance mutation(s) and Sponsor approval for study inclusion obtained. If the patient was intolerant to the drug, then mutational analysis and Sponsor approval are not required for enrollment.
Exclusion:
1. Has had tumor evaluated for PTEN and AKT and has known mutations or deletions in PTEN, or, activating mutations in AKT (E17K) determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory (e.g., ISO15189-certified, in-house clinical testing).
2. Metaplastic breast cancer
3. Possible allergies to TOS-358 or excipients
For pre-screening, please contact: Message Basket: P VICC RESEARCH BREAST OHO
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VICCMD2132
Ph2 Study of Belzutifan MonoTx in Advanced PPGL, pNET, VHL-Tumors, wt GIST, or HIF-2a Tumors
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Drug(s)/Mechanism:
Belzutifan
Eligiblity information:
Cohort B1 specific inclusion criteria:
1. Have a diagnosis of VHL disease as determined by a germline test (documented germline VHL gene alteration) locally and/or clinical diagnosis, which can be made in the
following instances:
a. in a participant with a family history of VHL disease and at least one of the characteristic VHL-related tumors (eg, retinal HBs, CNS HBs, clear cell RCCs, pNETs, and endolymphatic sac tumors).
b. in the presence of 2 or more retinal or CNS HBs.
c. in the presence of 1 retinal or CNS HB, plus at least 1 of the characteristic VHLrelated visceral tumors, excluding renal and epididymal cysts.
2. Have at least 1 measurable PPGL or pNET per RECIST 1.1 by CT or MRI as assessed by local site investigator/radiology assessment and verified by BICR. BICR must verify the
presence of radiologically measurable disease per RECIST 1.1 for either PPGL or pNET for the participant to be eligible for the study.
3. For Cohort B1 participants with PPGL:
a. No pheochromocytoma >5 cm or paraganglioma >4 cm that requires immediate surgery.
b. Participants should have adequately controlled BP defined as BP 150/90 mm Hg and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 2 weeks prior to start of study treatment.
c. Metastatic or locally advanced, unresectable PPGL will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
4. For Cohort B1 participants with pNET:
a. No lesion(s) located in the head of the pancreas must be >2 cm that requires immediate surgery.
b. No lesion(s) located in the body or tail of the pancreas must be >3 cm that requires immediate surgery.
c. Locally advanced, unresectable or metastatic pNET will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
5. For Cohort B1 participants with RCC:
a. No lesion(s) must be >3 cm that requires immediate surgery.
b. Metastatic RCC will be exclusionary.
c. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
6. For Cohort D participants with advanced solid tumors with HIF-2A related genetic alterations:
a. Local test report documenting germline or somatic mutations in at least one of the HIF-2A related genes (HIF-2A/EPAS1, FH, SDHA, SDHB, SDHC, SDHD, SDHAF2, EGLN1, EGLN2, MDH2, ELOC/TCEB1).
b. Has locally advanced or metastatic solid tumor that is not amenable to surgery or curative intent treatment.
c. Participants must have progressed on/after standard therapy for advanced/metastatic disease. More than 3 prior therapies will not be allowed for this cohort in the advanced/metastatic setting.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-NTMDT23238
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
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Inclusion Criteria:
1. Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider.
2. All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
3. Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
4. Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
- Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response [CR] or partial response [PR]) to any intervening therapy after collection of the tissue
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
5. Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
* NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only
*NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICCURO24518
Phase 1 Study of LOXO-435 (LY3866288) In Adv. Solid Tumors with FGFR3 Alterations Inc. Urothelial
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologic diagnosis of locally advanced or metastatic solid tumor malignancy (except CNS primary malignancy, for example, glioma), and where applicable, with an FGFR3 pathway alteration listed in Section 10.8, on molecular testing in tumor or blood sample that is deemed as actionable, as defined below per specified cohort.
2. Cohort B: Locally Advanced or Metastatic Urothelial Carcinoma
a. B1: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib and EV
b. B2: LOXO-435 monotherapy- mUC, Qualifying FGFR3 alterations, ≥1 prior regimen, FGFR inhibitor naïve
c. B4: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib; EV naïve
d. B5: LOXO-435 + Pembrolizumab + EV- mUC, Qualifying FGFR3 alterations, No prior systemic therapy
3. Cohort C: Locally Advanced or Metastatic Solid Tumors (Non-Urothelial Carcinoma)
a. C1: LOXO-435 monotherapy- Qualifying FGFR3 alterations, Progressed/intolerant to available standard therapies, FGFR inhibitor naïve
4. Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
Exclusion Criteria:
1. Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible.
2. For Cohort B5 only, individuals with known uncontrolled diabetes.
3. For Cohorts B3 and B5 only, individuals with a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
4. Individuals with uncontrolled hypercalcemia <14 days to C1D1.
For pre-screening, please contact: Individual disease research teams.
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VICC-DTMDT24023
Ph1/2 Study of YH32367 in Patients with HER2 + Locally Advanced or Metastatic Solid Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Dose Expansion only:
a. Patients who have at least one measurable lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline >/=10 mm in the longest diameter.
b. Mandatory provision of tumor tissue sample from a recent biopsy in a quantity sufficient to allow for analysis
c. All patients with biliary tract cancer or other solid tumor malignancies should have HER2 testing performed using a local laboratory
d. Cohort 1
i. Confirmed HER2-positive (IHC3+, or IHC2+ and ISH*+), locally advanced/unresectable or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary adenocarcinoma (*ISH: FISH, SISH, or DISH)
ii. Failed or intolerant to at least 1 prior gemcitabine- and/or cisplatin-based therapy with/without immune checkpoint inhibitors as per available local standards
e. Cohort 2
i. Pathologically confirmed HER2-positive (IHC3+, or IHC2+ and ISH*+), locally advanced/unresectable or metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer (*ISH: FISH, SISH, or DISH)
ii. Patients who have received all available standard therapies known to provide clinical benefit, and have no currently available treatment options due to disease progression, intolerance or other reasons
Exclusion Criteria:
1. History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis.
2. Systemic steroid therapy (>10 mg daily prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
3. Previous treatment with a 4-1BB/CD137-modulating agent.
For pre-screening, please contact: Your disease specific research team.
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VICCPHI25051
Open-Label Study of BBO-11818 in Adult Subjects with KRAS Mutant Cancer
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
2. Measurable disease by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria:
1. Malignancy within the last 2 years as specified in the protocol
2. Untreated brain metastases
3. Known hypersensitivity to BBO-11818 or its excipients
For pre-screening, please contact: VICC RESEARCH PHASE 1
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VICCPHI24572
A Study of CLSP-1025 in Adult Patients with Solid Tumors that Harbor the p53 R175H Mutation
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Key Eligibility Criteria:
Inclusion Criteria:
1. Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test
2. Patients must be HLA-A*02:01 positive by central assay
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
Exclusion Criteria:
1. Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation
2. Patients who have received other p53 R175H-directed therapies
3. Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission.
4. Known active central nervous system metastases and/or carcinomatous meningitis
For pre-screening, please contact: VICC RESEARCH PHASE 1
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VICC-DTPHI23579
Ph I Study of Pan-RAF/MEK Glue NST-628 in Solid Tumors w/without MAPK Pathway Genetic Alterations
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Key Eligibility Criteria:
Inclusion Criteria:
1. Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy.
Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test:
i. Melanoma Cohort(s):
1. Activating NRAS mutations& without known concomitant activating PIK3CA, AKT mutation or PTEN LOF
2. BRAF Class 2/3 mutations or fusions
ii. Non-Melanoma Cohorts:
1. Solid tumors with NRAS activating mutations& without known concomitant activating PIK3CA, AKT mutation or PTEN LOF
2. Solid tumors with KRAS activating mutations without known concomitant activating PIK3CA, AKT mutation of PTEN LOF
3. Solid tumors with BRAF Class 2/3 mutations or fusions
4. Glioma with BRAF Class 1, 2, or 3 mutations or fusions
2. Newly obtained or archived tumor tissue is required
Exclusion Criteria:
1. Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)
2. Part B: prior treatment with any MEK or BRAF inhibitor
3. A history or current evidence of significant retinal pathology leading to increased risk of retinal vein occlusion
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Sarcoma
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VICCMDP2287
OL Mltcntr FIH Ph1 Dose-Esc & Mltchrt Exp INBRX-109 Subj w/Loc Adv or Metast Sol Tum Incl Sarcomas
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Key Eligibility Criteria:
Inclusion Criteria:
1. Males or females aged >/= 12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.
2. Part 3 combination therapy expansion tumor types:
- Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.
- Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.
3. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria:
1. Prior treatment with or exposure to DR5 agonists.
2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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Melanoma
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VICCPHI2254
PH1/1b, OL BCA101 Monotherapy & In Combination Therapy Pts w/EGFR-Driven Advanced Solid Tumors
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Eligibility Criteria
Inclusion Criteria:
1. Single agent BCA101 - patients with the following tumor type will be eligible:
a. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
a. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
b. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
c. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
d. Patients must have progressed on one prior systemic therapy in the metastatic setting.
e. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
f. Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab -Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
Exclusion Criteria:
1. Prior treatment with any anti-TGFb therapy.
2. Has a history of (non-infectious) pneumonitis, radiation pneumonitis or interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICC-DTPHI23579
Ph I Study of Pan-RAF/MEK Glue NST-628 in Solid Tumors w/without MAPK Pathway Genetic Alterations
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Key Eligibility Criteria:
Inclusion Criteria:
1. Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy.
Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test:
i. Melanoma Cohort(s):
1. Activating NRAS mutations& without known concomitant activating PIK3CA, AKT mutation or PTEN LOF
2. BRAF Class 2/3 mutations or fusions
ii. Non-Melanoma Cohorts:
1. Solid tumors with NRAS activating mutations& without known concomitant activating PIK3CA, AKT mutation or PTEN LOF
2. Solid tumors with KRAS activating mutations without known concomitant activating PIK3CA, AKT mutation of PTEN LOF
3. Solid tumors with BRAF Class 2/3 mutations or fusions
4. Glioma with BRAF Class 1, 2, or 3 mutations or fusions
2. Newly obtained or archived tumor tissue is required
Exclusion Criteria:
1. Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)
2. Part B: prior treatment with any MEK or BRAF inhibitor
3. A history or current evidence of significant retinal pathology leading to increased risk of retinal vein occlusion
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Head and Neck
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VICCPHI2254
PH1/1b, OL BCA101 Monotherapy & In Combination Therapy Pts w/EGFR-Driven Advanced Solid Tumors
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Eligibility Criteria
Inclusion Criteria:
1. Single agent BCA101 - patients with the following tumor type will be eligible:
a. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
a. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
b. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
c. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
d. Patients must have progressed on one prior systemic therapy in the metastatic setting.
e. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
f. Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab -Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
Exclusion Criteria:
1. Prior treatment with any anti-TGFb therapy.
2. Has a history of (non-infectious) pneumonitis, radiation pneumonitis or interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23103
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. For Phase 1b: locally advanced, recurrent, or metastatic, incurable, and histologically or cytologically confirmed HR+/HER2- breast cancer by ASCO/CAP criteria (based on most recent assessment):
a) Must have received CDK4/6i in the adjuvant or metastatic setting, unless patient was unable or unwilling to receive standard of care CDK4/6i treatment; or must be able to receive it on protocol, AND,
b) Received no more than 1 prior line of therapy containing chemotherapy (including cytotoxic antibody-drug conjugates) given in the metastatic setting; AND,
c) Must have received no more than 3 lines of therapy in total for metastatic disease.
d) May have received a prior PI3Ka inhibitor
NOTE: If the patient progressed on the PI3K inhibitor a sample (tissue or liquid) must have been obtained following progression, or at study screening, to be analyzed at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory, determine the resistance mutation(s) and Sponsor approval for study inclusion obtained. If the patient was intolerant to the drug, then mutational analysis and Sponsor approval are not required for enrollment.
Exclusion:
1. Has had tumor evaluated for PTEN and AKT and has known mutations or deletions in PTEN, or, activating mutations in AKT (E17K) determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory (e.g., ISO15189-certified, in-house clinical testing).
2. Metaplastic breast cancer
3. Possible allergies to TOS-358 or excipients
For pre-screening, please contact: Message Basket: P VICC RESEARCH BREAST OHO
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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Lung
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICCPHI2254
PH1/1b, OL BCA101 Monotherapy & In Combination Therapy Pts w/EGFR-Driven Advanced Solid Tumors
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Eligibility Criteria
Inclusion Criteria:
1. Single agent BCA101 - patients with the following tumor type will be eligible:
a. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
a. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
b. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
c. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
d. Patients must have progressed on one prior systemic therapy in the metastatic setting.
e. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
f. Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab -Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
Exclusion Criteria:
1. Prior treatment with any anti-TGFb therapy.
2. Has a history of (non-infectious) pneumonitis, radiation pneumonitis or interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICCPHI2207
Ph1 of ASP3082 Pts w/Prev Tx Locally Adv or Metastatic Solid Tumor Malignancies w/KRAS G12D Mutation
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICCPHI25051
Open-Label Study of BBO-11818 in Adult Subjects with KRAS Mutant Cancer
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
2. Measurable disease by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria:
1. Malignancy within the last 2 years as specified in the protocol
2. Untreated brain metastases
3. Known hypersensitivity to BBO-11818 or its excipients
For pre-screening, please contact: VICC RESEARCH PHASE 1
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Prostate
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICC-DTPHI24194
Phase 1 study of DCC-2812 in Advanced or Metastatic RCC, UC, or CRPC
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Key Eligibility Criteria:
Inclusion Criteria:
1. Must have one of the following diagnoses under study:
a. RCC: Have histologically or cytologically confirmed advanced or metastatic RCC and have progressed on, are intolerant to, or have a contraindication to treatment with a VEGFR-TKI and an anti-PD-(L)1 antibody.
b. Urothelial carcinoma: Have histologically or cytologically confirmed advanced or metastatic urothelial carcinoma and have progressed on, are intolerant to, or have a contraindication to treatment with an anti-PD-(L)1 antibody and enfortumab vedotin-ejfv. Participants with susceptible FGFR3 or FGFR2 tumor genetic alterations must have progressed on, be intolerant to, or have a contraindication to treatment with an FGFR inhibitor, if approved and available in the study site's region.
c. Castration-resistant prostate cancer: Have a histologically or cytologically confirmed advanced or metastatic prostate cancer after treatment with at least 1 androgen receptor signaling inhibitor (such as abiraterone, enzalutamide, apalutamide, and darolutamide). Participants with prostate cancer must also fulfill both of the following:
i. Ongoing androgen deprivation from prior orchiectomy or continued luteinizing hormone-releasing hormone agonist or antagonist therapy with leuprolide, goserelin, buserelin, triptorelin, or degarelix and a Screening testosterone level of 50 ng/dL or less.
ii. At least 1 metastatic lesion outside the prostate and at least one of the following: any soft tissue lesion that is measurable according to RECIST v1.1 and/or a PSA level of at least 1 ng/mL.
Exclusion Criteria:
1. Has history of systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or moderate hemoptysis within 6 months prior to the first dose of study drug.
2. Has history of systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) unless they have been on stable anticoagulation for at least 30 days or the event has completely resolved and there is no need for ongoing treatment.
For pre-screening, please contact: VICC RESEARCH PHASE 1
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Kidney
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICCMD2132
Ph2 Study of Belzutifan MonoTx in Advanced PPGL, pNET, VHL-Tumors, wt GIST, or HIF-2a Tumors
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Drug(s)/Mechanism:
Belzutifan
Eligiblity information:
Cohort B1 specific inclusion criteria:
1. Have a diagnosis of VHL disease as determined by a germline test (documented germline VHL gene alteration) locally and/or clinical diagnosis, which can be made in the
following instances:
a. in a participant with a family history of VHL disease and at least one of the characteristic VHL-related tumors (eg, retinal HBs, CNS HBs, clear cell RCCs, pNETs, and endolymphatic sac tumors).
b. in the presence of 2 or more retinal or CNS HBs.
c. in the presence of 1 retinal or CNS HB, plus at least 1 of the characteristic VHLrelated visceral tumors, excluding renal and epididymal cysts.
2. Have at least 1 measurable PPGL or pNET per RECIST 1.1 by CT or MRI as assessed by local site investigator/radiology assessment and verified by BICR. BICR must verify the
presence of radiologically measurable disease per RECIST 1.1 for either PPGL or pNET for the participant to be eligible for the study.
3. For Cohort B1 participants with PPGL:
a. No pheochromocytoma >5 cm or paraganglioma >4 cm that requires immediate surgery.
b. Participants should have adequately controlled BP defined as BP 150/90 mm Hg and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 2 weeks prior to start of study treatment.
c. Metastatic or locally advanced, unresectable PPGL will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
4. For Cohort B1 participants with pNET:
a. No lesion(s) located in the head of the pancreas must be >2 cm that requires immediate surgery.
b. No lesion(s) located in the body or tail of the pancreas must be >3 cm that requires immediate surgery.
c. Locally advanced, unresectable or metastatic pNET will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
5. For Cohort B1 participants with RCC:
a. No lesion(s) must be >3 cm that requires immediate surgery.
b. Metastatic RCC will be exclusionary.
c. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
6. For Cohort D participants with advanced solid tumors with HIF-2A related genetic alterations:
a. Local test report documenting germline or somatic mutations in at least one of the HIF-2A related genes (HIF-2A/EPAS1, FH, SDHA, SDHB, SDHC, SDHD, SDHAF2, EGLN1, EGLN2, MDH2, ELOC/TCEB1).
b. Has locally advanced or metastatic solid tumor that is not amenable to surgery or curative intent treatment.
c. Participants must have progressed on/after standard therapy for advanced/metastatic disease. More than 3 prior therapies will not be allowed for this cohort in the advanced/metastatic setting.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICC-DTPHI24194
Phase 1 study of DCC-2812 in Advanced or Metastatic RCC, UC, or CRPC
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Key Eligibility Criteria:
Inclusion Criteria:
1. Must have one of the following diagnoses under study:
a. RCC: Have histologically or cytologically confirmed advanced or metastatic RCC and have progressed on, are intolerant to, or have a contraindication to treatment with a VEGFR-TKI and an anti-PD-(L)1 antibody.
b. Urothelial carcinoma: Have histologically or cytologically confirmed advanced or metastatic urothelial carcinoma and have progressed on, are intolerant to, or have a contraindication to treatment with an anti-PD-(L)1 antibody and enfortumab vedotin-ejfv. Participants with susceptible FGFR3 or FGFR2 tumor genetic alterations must have progressed on, be intolerant to, or have a contraindication to treatment with an FGFR inhibitor, if approved and available in the study site's region.
c. Castration-resistant prostate cancer: Have a histologically or cytologically confirmed advanced or metastatic prostate cancer after treatment with at least 1 androgen receptor signaling inhibitor (such as abiraterone, enzalutamide, apalutamide, and darolutamide). Participants with prostate cancer must also fulfill both of the following:
i. Ongoing androgen deprivation from prior orchiectomy or continued luteinizing hormone-releasing hormone agonist or antagonist therapy with leuprolide, goserelin, buserelin, triptorelin, or degarelix and a Screening testosterone level of 50 ng/dL or less.
ii. At least 1 metastatic lesion outside the prostate and at least one of the following: any soft tissue lesion that is measurable according to RECIST v1.1 and/or a PSA level of at least 1 ng/mL.
Exclusion Criteria:
1. Has history of systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or moderate hemoptysis within 6 months prior to the first dose of study drug.
2. Has history of systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) unless they have been on stable anticoagulation for at least 30 days or the event has completely resolved and there is no need for ongoing treatment.
For pre-screening, please contact: VICC RESEARCH PHASE 1
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Bladder
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VICC-DTPHI23103
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. For Phase 1b: locally advanced, recurrent, or metastatic, incurable, and histologically or cytologically confirmed HR+/HER2- breast cancer by ASCO/CAP criteria (based on most recent assessment):
a) Must have received CDK4/6i in the adjuvant or metastatic setting, unless patient was unable or unwilling to receive standard of care CDK4/6i treatment; or must be able to receive it on protocol, AND,
b) Received no more than 1 prior line of therapy containing chemotherapy (including cytotoxic antibody-drug conjugates) given in the metastatic setting; AND,
c) Must have received no more than 3 lines of therapy in total for metastatic disease.
d) May have received a prior PI3Ka inhibitor
NOTE: If the patient progressed on the PI3K inhibitor a sample (tissue or liquid) must have been obtained following progression, or at study screening, to be analyzed at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory, determine the resistance mutation(s) and Sponsor approval for study inclusion obtained. If the patient was intolerant to the drug, then mutational analysis and Sponsor approval are not required for enrollment.
Exclusion:
1. Has had tumor evaluated for PTEN and AKT and has known mutations or deletions in PTEN, or, activating mutations in AKT (E17K) determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory (e.g., ISO15189-certified, in-house clinical testing).
2. Metaplastic breast cancer
3. Possible allergies to TOS-358 or excipients
For pre-screening, please contact: Message Basket: P VICC RESEARCH BREAST OHO
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICCURO24518
Phase 1 Study of LOXO-435 (LY3866288) In Adv. Solid Tumors with FGFR3 Alterations Inc. Urothelial
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologic diagnosis of locally advanced or metastatic solid tumor malignancy (except CNS primary malignancy, for example, glioma), and where applicable, with an FGFR3 pathway alteration listed in Section 10.8, on molecular testing in tumor or blood sample that is deemed as actionable, as defined below per specified cohort.
2. Cohort B: Locally Advanced or Metastatic Urothelial Carcinoma
a. B1: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib and EV
b. B2: LOXO-435 monotherapy- mUC, Qualifying FGFR3 alterations, ≥1 prior regimen, FGFR inhibitor naïve
c. B4: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib; EV naïve
d. B5: LOXO-435 + Pembrolizumab + EV- mUC, Qualifying FGFR3 alterations, No prior systemic therapy
3. Cohort C: Locally Advanced or Metastatic Solid Tumors (Non-Urothelial Carcinoma)
a. C1: LOXO-435 monotherapy- Qualifying FGFR3 alterations, Progressed/intolerant to available standard therapies, FGFR inhibitor naïve
4. Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
Exclusion Criteria:
1. Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible.
2. For Cohort B5 only, individuals with known uncontrolled diabetes.
3. For Cohorts B3 and B5 only, individuals with a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
4. Individuals with uncontrolled hypercalcemia <14 days to C1D1.
For pre-screening, please contact: Individual disease research teams.
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VICC-DTPHI24194
Phase 1 study of DCC-2812 in Advanced or Metastatic RCC, UC, or CRPC
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Key Eligibility Criteria:
Inclusion Criteria:
1. Must have one of the following diagnoses under study:
a. RCC: Have histologically or cytologically confirmed advanced or metastatic RCC and have progressed on, are intolerant to, or have a contraindication to treatment with a VEGFR-TKI and an anti-PD-(L)1 antibody.
b. Urothelial carcinoma: Have histologically or cytologically confirmed advanced or metastatic urothelial carcinoma and have progressed on, are intolerant to, or have a contraindication to treatment with an anti-PD-(L)1 antibody and enfortumab vedotin-ejfv. Participants with susceptible FGFR3 or FGFR2 tumor genetic alterations must have progressed on, be intolerant to, or have a contraindication to treatment with an FGFR inhibitor, if approved and available in the study site's region.
c. Castration-resistant prostate cancer: Have a histologically or cytologically confirmed advanced or metastatic prostate cancer after treatment with at least 1 androgen receptor signaling inhibitor (such as abiraterone, enzalutamide, apalutamide, and darolutamide). Participants with prostate cancer must also fulfill both of the following:
i. Ongoing androgen deprivation from prior orchiectomy or continued luteinizing hormone-releasing hormone agonist or antagonist therapy with leuprolide, goserelin, buserelin, triptorelin, or degarelix and a Screening testosterone level of 50 ng/dL or less.
ii. At least 1 metastatic lesion outside the prostate and at least one of the following: any soft tissue lesion that is measurable according to RECIST v1.1 and/or a PSA level of at least 1 ng/mL.
Exclusion Criteria:
1. Has history of systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or moderate hemoptysis within 6 months prior to the first dose of study drug.
2. Has history of systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) unless they have been on stable anticoagulation for at least 30 days or the event has completely resolved and there is no need for ongoing treatment.
For pre-screening, please contact: VICC RESEARCH PHASE 1
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Brain Cancers
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VICC-DTPHI23045
Ph I/IIa Study of [212Pb]VMT-a-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 + Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Adult PRRT-naïve subjects with NETs or meningioma by local pathology
2. Disease described clinically as:
(a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study
(b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study
(c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.
3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3)
4. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
5. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.
6. Demonstration of lesional SSTR expression:
(a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. [68Ga]DOTATATE, [64Cu]DOTATATE, or [68Ga]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment
Exclusion Criteria:
1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-a-NET.
2. Known additional malignancy that is progressing or requires active treatment.
3. Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)
4. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
5. For Subjects with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.
6. QTc > 450 milliseconds for males and females.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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Ovarian
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICCPHI24591
PHST001 in Adult Patients with Advanced Relapsed and/or Refractory Solid Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. Carcinosarcomas are also eligible.
b) Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had disease progression between 3 and 6 months after their last dose. Participants who had previously received two or three lines of platinum-based therapy must have had disease progression while receiving the therapy or within 6 months after the last dose.
c) At least 1 but no more than 4 prior lines of systemic therapy.
2. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Histologically confirmed endometrial adenocarcinoma regardless of mismatch repair deficiency status.
b)Relapsed or progressive disease after at least one prior line of systemic therapy.
c)Disease not amenable to curative surgery or radiation.
d)At least 1 but no more than 3 prior lines of systemic therapy in any setting. Prior endocrine therapy is not counted as a prior line of systemic therapy.
Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Histologically or cytologically confirmed advanced cholangiocarcinoma (intrahepatic, extrahepatic, or hilar). Advanced gallbladder adenocarcinomas are also eligible. Ampullary carcinomas are not eligible in Phase 1b.
b) Unresectable, locally advanced, or metastatic disease.
c) Disease progression during or after at least one prior line of systemic therapy for advanced disease.
d) At least 1 but no more than 3 prior lines of systemic therapy for advanced disease.
Exclusion Criteria:
1. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
2. Participant has received previous treatment with another agent targeting CD24.
3. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Non-epithelial ovarian tumors or ovarian tumors of low malignant potential
4. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Carcinosarcoma histology
5. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Ampullary carcinoma (unless specifically cholangiocarcinoma histology)
b) Gallbladder cancers other than adenocarcinomas.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Cervical
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VICC-NTPHI23420
Phase I trial of ZEN003694 in Combination with Capecitabine in Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
2. Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
3. Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU or capecitabine
4. Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Exclusion:
1. Previous treatment with BET inhibitors
2. History of inability to tolerate capecitabine at the projected treatment dose on this trial
3. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
4. Hepatic tumor burden > 30% or peritoneal carcinomatosis
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICCURO24518
Phase 1 Study of LOXO-435 (LY3866288) In Adv. Solid Tumors with FGFR3 Alterations Inc. Urothelial
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologic diagnosis of locally advanced or metastatic solid tumor malignancy (except CNS primary malignancy, for example, glioma), and where applicable, with an FGFR3 pathway alteration listed in Section 10.8, on molecular testing in tumor or blood sample that is deemed as actionable, as defined below per specified cohort.
2. Cohort B: Locally Advanced or Metastatic Urothelial Carcinoma
a. B1: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib and EV
b. B2: LOXO-435 monotherapy- mUC, Qualifying FGFR3 alterations, ≥1 prior regimen, FGFR inhibitor naïve
c. B4: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib; EV naïve
d. B5: LOXO-435 + Pembrolizumab + EV- mUC, Qualifying FGFR3 alterations, No prior systemic therapy
3. Cohort C: Locally Advanced or Metastatic Solid Tumors (Non-Urothelial Carcinoma)
a. C1: LOXO-435 monotherapy- Qualifying FGFR3 alterations, Progressed/intolerant to available standard therapies, FGFR inhibitor naïve
4. Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
Exclusion Criteria:
1. Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible.
2. For Cohort B5 only, individuals with known uncontrolled diabetes.
3. For Cohorts B3 and B5 only, individuals with a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
4. Individuals with uncontrolled hypercalcemia <14 days to C1D1.
For pre-screening, please contact: Individual disease research teams.
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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Endometrial
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VICC-DTPHI23103
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. For Phase 1b: locally advanced, recurrent, or metastatic, incurable, and histologically or cytologically confirmed HR+/HER2- breast cancer by ASCO/CAP criteria (based on most recent assessment):
a) Must have received CDK4/6i in the adjuvant or metastatic setting, unless patient was unable or unwilling to receive standard of care CDK4/6i treatment; or must be able to receive it on protocol, AND,
b) Received no more than 1 prior line of therapy containing chemotherapy (including cytotoxic antibody-drug conjugates) given in the metastatic setting; AND,
c) Must have received no more than 3 lines of therapy in total for metastatic disease.
d) May have received a prior PI3Ka inhibitor
NOTE: If the patient progressed on the PI3K inhibitor a sample (tissue or liquid) must have been obtained following progression, or at study screening, to be analyzed at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory, determine the resistance mutation(s) and Sponsor approval for study inclusion obtained. If the patient was intolerant to the drug, then mutational analysis and Sponsor approval are not required for enrollment.
Exclusion:
1. Has had tumor evaluated for PTEN and AKT and has known mutations or deletions in PTEN, or, activating mutations in AKT (E17K) determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory (e.g., ISO15189-certified, in-house clinical testing).
2. Metaplastic breast cancer
3. Possible allergies to TOS-358 or excipients
For pre-screening, please contact: Message Basket: P VICC RESEARCH BREAST OHO
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VICCPHI24591
PHST001 in Adult Patients with Advanced Relapsed and/or Refractory Solid Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. Carcinosarcomas are also eligible.
b) Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had disease progression between 3 and 6 months after their last dose. Participants who had previously received two or three lines of platinum-based therapy must have had disease progression while receiving the therapy or within 6 months after the last dose.
c) At least 1 but no more than 4 prior lines of systemic therapy.
2. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Histologically confirmed endometrial adenocarcinoma regardless of mismatch repair deficiency status.
b)Relapsed or progressive disease after at least one prior line of systemic therapy.
c)Disease not amenable to curative surgery or radiation.
d)At least 1 but no more than 3 prior lines of systemic therapy in any setting. Prior endocrine therapy is not counted as a prior line of systemic therapy.
Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Histologically or cytologically confirmed advanced cholangiocarcinoma (intrahepatic, extrahepatic, or hilar). Advanced gallbladder adenocarcinomas are also eligible. Ampullary carcinomas are not eligible in Phase 1b.
b) Unresectable, locally advanced, or metastatic disease.
c) Disease progression during or after at least one prior line of systemic therapy for advanced disease.
d) At least 1 but no more than 3 prior lines of systemic therapy for advanced disease.
Exclusion Criteria:
1. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
2. Participant has received previous treatment with another agent targeting CD24.
3. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Non-epithelial ovarian tumors or ovarian tumors of low malignant potential
4. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Carcinosarcoma histology
5. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Ampullary carcinoma (unless specifically cholangiocarcinoma histology)
b) Gallbladder cancers other than adenocarcinomas.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Colorectal
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VICC-NTPHI23420
Phase I trial of ZEN003694 in Combination with Capecitabine in Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
2. Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
3. Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU or capecitabine
4. Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Exclusion:
1. Previous treatment with BET inhibitors
2. History of inability to tolerate capecitabine at the projected treatment dose on this trial
3. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
4. Hepatic tumor burden > 30% or peritoneal carcinomatosis
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICCPHI2207
Ph1 of ASP3082 Pts w/Prev Tx Locally Adv or Metastatic Solid Tumor Malignancies w/KRAS G12D Mutation
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICCMDP2287
OL Mltcntr FIH Ph1 Dose-Esc & Mltchrt Exp INBRX-109 Subj w/Loc Adv or Metast Sol Tum Incl Sarcomas
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Key Eligibility Criteria:
Inclusion Criteria:
1. Males or females aged >/= 12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.
2. Part 3 combination therapy expansion tumor types:
- Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.
- Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.
3. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria:
1. Prior treatment with or exposure to DR5 agonists.
2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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VICCPHI25051
Open-Label Study of BBO-11818 in Adult Subjects with KRAS Mutant Cancer
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
2. Measurable disease by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria:
1. Malignancy within the last 2 years as specified in the protocol
2. Untreated brain metastases
3. Known hypersensitivity to BBO-11818 or its excipients
For pre-screening, please contact: VICC RESEARCH PHASE 1
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VICCPHI2254
PH1/1b, OL BCA101 Monotherapy & In Combination Therapy Pts w/EGFR-Driven Advanced Solid Tumors
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Eligibility Criteria
Inclusion Criteria:
1. Single agent BCA101 - patients with the following tumor type will be eligible:
a. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
a. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
b. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
c. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
d. Patients must have progressed on one prior systemic therapy in the metastatic setting.
e. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
f. Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab -Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
Exclusion Criteria:
1. Prior treatment with any anti-TGFb therapy.
2. Has a history of (non-infectious) pneumonitis, radiation pneumonitis or interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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Gastroesophageal
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VICCMDP2287
OL Mltcntr FIH Ph1 Dose-Esc & Mltchrt Exp INBRX-109 Subj w/Loc Adv or Metast Sol Tum Incl Sarcomas
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Key Eligibility Criteria:
Inclusion Criteria:
1. Males or females aged >/= 12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.
2. Part 3 combination therapy expansion tumor types:
- Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.
- Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.
3. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria:
1. Prior treatment with or exposure to DR5 agonists.
2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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VICC-NTPHI23420
Phase I trial of ZEN003694 in Combination with Capecitabine in Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
2. Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
3. Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU or capecitabine
4. Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Exclusion:
1. Previous treatment with BET inhibitors
2. History of inability to tolerate capecitabine at the projected treatment dose on this trial
3. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
4. Hepatic tumor burden > 30% or peritoneal carcinomatosis
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
-
-
ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
-
Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
-
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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Anal
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VICCPHI2254
PH1/1b, OL BCA101 Monotherapy & In Combination Therapy Pts w/EGFR-Driven Advanced Solid Tumors
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Eligibility Criteria
Inclusion Criteria:
1. Single agent BCA101 - patients with the following tumor type will be eligible:
a. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
a. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
b. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
c. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
d. Patients must have progressed on one prior systemic therapy in the metastatic setting.
e. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
f. Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab -Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
Exclusion Criteria:
1. Prior treatment with any anti-TGFb therapy.
2. Has a history of (non-infectious) pneumonitis, radiation pneumonitis or interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
-
-
ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
-
Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Pancreas
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VICCPHI2207
Ph1 of ASP3082 Pts w/Prev Tx Locally Adv or Metastatic Solid Tumor Malignancies w/KRAS G12D Mutation
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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VICC-NTPHI23420
Phase I trial of ZEN003694 in Combination with Capecitabine in Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
2. Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
3. Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU or capecitabine
4. Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Exclusion:
1. Previous treatment with BET inhibitors
2. History of inability to tolerate capecitabine at the projected treatment dose on this trial
3. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
4. Hepatic tumor burden > 30% or peritoneal carcinomatosis
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23183
A Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants
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Key Eligibility Criteria:
Inclusion Criteria:
1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
3. Radiographically documented progressive disease on or after the most recent therapy.
4. Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
5. Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
6. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease.
Exclusion Criteria:
1. Primary central nervous system (CNS) malignancy.
2. Untreated CNS metastases.
3. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
4. Active, known, or suspected autoimmune disease.
5. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
6. History of or with active interstitial lung disease or pulmonary fibrosis.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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VICCPHI25051
Open-Label Study of BBO-11818 in Adult Subjects with KRAS Mutant Cancer
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
2. Measurable disease by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria:
1. Malignancy within the last 2 years as specified in the protocol
2. Untreated brain metastases
3. Known hypersensitivity to BBO-11818 or its excipients
For pre-screening, please contact: VICC RESEARCH PHASE 1
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VICCPHI2289
PHI a/b RBS2418 Monotherapy& w/Pembrolizumab Pts w/Adv Unresectable, Recurrent or Metastatic Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
2. Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. Additionally, during the dose-escalation portion and if appropriate in the expansion phase of the study, the Sponsor may modify subject enrolment into various cohorts that have not begun enrolling yet such that ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study.
Exclusion Criteria:
1. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
4. History or any evidence of interstitial lung disease
For internal pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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Hepatocellular
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VICC-DTMDT24023
Ph1/2 Study of YH32367 in Patients with HER2 + Locally Advanced or Metastatic Solid Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Dose Expansion only:
a. Patients who have at least one measurable lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline >/=10 mm in the longest diameter.
b. Mandatory provision of tumor tissue sample from a recent biopsy in a quantity sufficient to allow for analysis
c. All patients with biliary tract cancer or other solid tumor malignancies should have HER2 testing performed using a local laboratory
d. Cohort 1
i. Confirmed HER2-positive (IHC3+, or IHC2+ and ISH*+), locally advanced/unresectable or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary adenocarcinoma (*ISH: FISH, SISH, or DISH)
ii. Failed or intolerant to at least 1 prior gemcitabine- and/or cisplatin-based therapy with/without immune checkpoint inhibitors as per available local standards
e. Cohort 2
i. Pathologically confirmed HER2-positive (IHC3+, or IHC2+ and ISH*+), locally advanced/unresectable or metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer (*ISH: FISH, SISH, or DISH)
ii. Patients who have received all available standard therapies known to provide clinical benefit, and have no currently available treatment options due to disease progression, intolerance or other reasons
Exclusion Criteria:
1. History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis.
2. Systemic steroid therapy (>10 mg daily prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
3. Previous treatment with a 4-1BB/CD137-modulating agent.
For pre-screening, please contact: Your disease specific research team.
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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Neuroendocrine
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VICCMD2132
Ph2 Study of Belzutifan MonoTx in Advanced PPGL, pNET, VHL-Tumors, wt GIST, or HIF-2a Tumors
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Drug(s)/Mechanism:
Belzutifan
Eligiblity information:
Cohort B1 specific inclusion criteria:
1. Have a diagnosis of VHL disease as determined by a germline test (documented germline VHL gene alteration) locally and/or clinical diagnosis, which can be made in the
following instances:
a. in a participant with a family history of VHL disease and at least one of the characteristic VHL-related tumors (eg, retinal HBs, CNS HBs, clear cell RCCs, pNETs, and endolymphatic sac tumors).
b. in the presence of 2 or more retinal or CNS HBs.
c. in the presence of 1 retinal or CNS HB, plus at least 1 of the characteristic VHLrelated visceral tumors, excluding renal and epididymal cysts.
2. Have at least 1 measurable PPGL or pNET per RECIST 1.1 by CT or MRI as assessed by local site investigator/radiology assessment and verified by BICR. BICR must verify the
presence of radiologically measurable disease per RECIST 1.1 for either PPGL or pNET for the participant to be eligible for the study.
3. For Cohort B1 participants with PPGL:
a. No pheochromocytoma >5 cm or paraganglioma >4 cm that requires immediate surgery.
b. Participants should have adequately controlled BP defined as BP 150/90 mm Hg and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 2 weeks prior to start of study treatment.
c. Metastatic or locally advanced, unresectable PPGL will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
4. For Cohort B1 participants with pNET:
a. No lesion(s) located in the head of the pancreas must be >2 cm that requires immediate surgery.
b. No lesion(s) located in the body or tail of the pancreas must be >3 cm that requires immediate surgery.
c. Locally advanced, unresectable or metastatic pNET will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
5. For Cohort B1 participants with RCC:
a. No lesion(s) must be >3 cm that requires immediate surgery.
b. Metastatic RCC will be exclusionary.
c. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
6. For Cohort D participants with advanced solid tumors with HIF-2A related genetic alterations:
a. Local test report documenting germline or somatic mutations in at least one of the HIF-2A related genes (HIF-2A/EPAS1, FH, SDHA, SDHB, SDHC, SDHD, SDHAF2, EGLN1, EGLN2, MDH2, ELOC/TCEB1).
b. Has locally advanced or metastatic solid tumor that is not amenable to surgery or curative intent treatment.
c. Participants must have progressed on/after standard therapy for advanced/metastatic disease. More than 3 prior therapies will not be allowed for this cohort in the advanced/metastatic setting.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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VICC-DTPHI23045
Ph I/IIa Study of [212Pb]VMT-a-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 + Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Adult PRRT-naïve subjects with NETs or meningioma by local pathology
2. Disease described clinically as:
(a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study
(b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study
(c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.
3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3)
4. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
5. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.
6. Demonstration of lesional SSTR expression:
(a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. [68Ga]DOTATATE, [64Cu]DOTATATE, or [68Ga]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment
Exclusion Criteria:
1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-a-NET.
2. Known additional malignancy that is progressing or requires active treatment.
3. Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)
4. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
5. For Subjects with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.
6. QTc > 450 milliseconds for males and females.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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Breast
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VICC-DTPHI23103
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. For Phase 1b: locally advanced, recurrent, or metastatic, incurable, and histologically or cytologically confirmed HR+/HER2- breast cancer by ASCO/CAP criteria (based on most recent assessment):
a) Must have received CDK4/6i in the adjuvant or metastatic setting, unless patient was unable or unwilling to receive standard of care CDK4/6i treatment; or must be able to receive it on protocol, AND,
b) Received no more than 1 prior line of therapy containing chemotherapy (including cytotoxic antibody-drug conjugates) given in the metastatic setting; AND,
c) Must have received no more than 3 lines of therapy in total for metastatic disease.
d) May have received a prior PI3Ka inhibitor
NOTE: If the patient progressed on the PI3K inhibitor a sample (tissue or liquid) must have been obtained following progression, or at study screening, to be analyzed at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory, determine the resistance mutation(s) and Sponsor approval for study inclusion obtained. If the patient was intolerant to the drug, then mutational analysis and Sponsor approval are not required for enrollment.
Exclusion:
1. Has had tumor evaluated for PTEN and AKT and has known mutations or deletions in PTEN, or, activating mutations in AKT (E17K) determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory (e.g., ISO15189-certified, in-house clinical testing).
2. Metaplastic breast cancer
3. Possible allergies to TOS-358 or excipients
For pre-screening, please contact: Message Basket: P VICC RESEARCH BREAST OHO
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VICC-NTPHI23420
Phase I trial of ZEN003694 in Combination with Capecitabine in Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
2. Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
3. Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU or capecitabine
4. Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Exclusion:
1. Previous treatment with BET inhibitors
2. History of inability to tolerate capecitabine at the projected treatment dose on this trial
3. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
4. Hepatic tumor burden > 30% or peritoneal carcinomatosis
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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VICC-DTPHI23348
Ph 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
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Key Eligibility Criteria:
Inclusion:
1. Patient has a histologically- or cytologically confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit:
a. For Patients in the Dose Escalation Part:
i. Platinum-resistant ovarian cancer (PROC)
1. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
2. Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
ii. Triple negative breast cancer (TNBC)
1. ER- and PR-negative with HER2 negative
2. HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
3. ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
iii. Squamous cell carcinoma of the anus (SCCA)
1. Patient with locally advanced ineligible for surgery is allowed.
iv. Squamous cell carcinoma of the head and neck (SCCHN)
v. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
vi. Uterine serous cancer (recurrent or persistent)
b. For Patients in the Dose Expansion Part:
i. Cohort A: PROC (same as above)
ii. Cohort B: TNBC (same as above)
iii. Cohort C: SCCA (same as above)
2. For Dose Expansion only: Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and, if only one target lesion is present, has not received prior radiotherapy to the target lesion
Exclusion:
1. Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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ETCMD10397
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)
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Key Eligibility Criteria:
Inclusion Criteria:
1. Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC).
2. COHORT A: Patient must have high Trop-2 protein expression (IHC 2+ or 3+) excluding advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer
3. COHORT B: Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) excluding advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer
4. COHORT C: Patient must have HER2 protein expression (IHC 2+ or 3+) excluding advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer
Exclusion Criteria:
1. Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study
3. History of interstitial lung disease or pneumonitis requiring steroid therapy
For pre-screening, please contact: Individual research disease teams.
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Other Cancer Types
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NHL
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Paraganglioma
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VICCMD2132
Ph2 Study of Belzutifan MonoTx in Advanced PPGL, pNET, VHL-Tumors, wt GIST, or HIF-2a Tumors
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Drug(s)/Mechanism:
Belzutifan
Eligiblity information:
Cohort B1 specific inclusion criteria:
1. Have a diagnosis of VHL disease as determined by a germline test (documented germline VHL gene alteration) locally and/or clinical diagnosis, which can be made in the
following instances:
a. in a participant with a family history of VHL disease and at least one of the characteristic VHL-related tumors (eg, retinal HBs, CNS HBs, clear cell RCCs, pNETs, and endolymphatic sac tumors).
b. in the presence of 2 or more retinal or CNS HBs.
c. in the presence of 1 retinal or CNS HB, plus at least 1 of the characteristic VHLrelated visceral tumors, excluding renal and epididymal cysts.
2. Have at least 1 measurable PPGL or pNET per RECIST 1.1 by CT or MRI as assessed by local site investigator/radiology assessment and verified by BICR. BICR must verify the
presence of radiologically measurable disease per RECIST 1.1 for either PPGL or pNET for the participant to be eligible for the study.
3. For Cohort B1 participants with PPGL:
a. No pheochromocytoma >5 cm or paraganglioma >4 cm that requires immediate surgery.
b. Participants should have adequately controlled BP defined as BP 150/90 mm Hg and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 2 weeks prior to start of study treatment.
c. Metastatic or locally advanced, unresectable PPGL will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
4. For Cohort B1 participants with pNET:
a. No lesion(s) located in the head of the pancreas must be >2 cm that requires immediate surgery.
b. No lesion(s) located in the body or tail of the pancreas must be >3 cm that requires immediate surgery.
c. Locally advanced, unresectable or metastatic pNET will be exclusionary.
d. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
5. For Cohort B1 participants with RCC:
a. No lesion(s) must be >3 cm that requires immediate surgery.
b. Metastatic RCC will be exclusionary.
c. Presence of concomitant VHL disease associated tumors is permitted as long as they do not require immediate surgery or intervention as applicable (see exclusion criteria #2d-2g).
6. For Cohort D participants with advanced solid tumors with HIF-2A related genetic alterations:
a. Local test report documenting germline or somatic mutations in at least one of the HIF-2A related genes (HIF-2A/EPAS1, FH, SDHA, SDHB, SDHC, SDHD, SDHAF2, EGLN1, EGLN2, MDH2, ELOC/TCEB1).
b. Has locally advanced or metastatic solid tumor that is not amenable to surgery or curative intent treatment.
c. Participants must have progressed on/after standard therapy for advanced/metastatic disease. More than 3 prior therapies will not be allowed for this cohort in the advanced/metastatic setting.
For pre-screening, please contact: Message Basket: VICC RESEARCH REFERRALS/ELIGIBILITY
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Cholangiocarcinoma
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VICCURO24518
Phase 1 Study of LOXO-435 (LY3866288) In Adv. Solid Tumors with FGFR3 Alterations Inc. Urothelial
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Key Eligibility Criteria:
Inclusion Criteria:
1. Histologic diagnosis of locally advanced or metastatic solid tumor malignancy (except CNS primary malignancy, for example, glioma), and where applicable, with an FGFR3 pathway alteration listed in Section 10.8, on molecular testing in tumor or blood sample that is deemed as actionable, as defined below per specified cohort.
2. Cohort B: Locally Advanced or Metastatic Urothelial Carcinoma
a. B1: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib and EV
b. B2: LOXO-435 monotherapy- mUC, Qualifying FGFR3 alterations, ≥1 prior regimen, FGFR inhibitor naïve
c. B4: LOXO-435 monotherapy- mUC, ≥2 prior regimens, including erdafitinib; EV naïve
d. B5: LOXO-435 + Pembrolizumab + EV- mUC, Qualifying FGFR3 alterations, No prior systemic therapy
3. Cohort C: Locally Advanced or Metastatic Solid Tumors (Non-Urothelial Carcinoma)
a. C1: LOXO-435 monotherapy- Qualifying FGFR3 alterations, Progressed/intolerant to available standard therapies, FGFR inhibitor naïve
4. Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
Exclusion Criteria:
1. Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible.
2. For Cohort B5 only, individuals with known uncontrolled diabetes.
3. For Cohorts B3 and B5 only, individuals with a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
4. Individuals with uncontrolled hypercalcemia <14 days to C1D1.
For pre-screening, please contact: Individual disease research teams.
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VICCPHI24591
PHST001 in Adult Patients with Advanced Relapsed and/or Refractory Solid Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. Carcinosarcomas are also eligible.
b) Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had disease progression between 3 and 6 months after their last dose. Participants who had previously received two or three lines of platinum-based therapy must have had disease progression while receiving the therapy or within 6 months after the last dose.
c) At least 1 but no more than 4 prior lines of systemic therapy.
2. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Histologically confirmed endometrial adenocarcinoma regardless of mismatch repair deficiency status.
b)Relapsed or progressive disease after at least one prior line of systemic therapy.
c)Disease not amenable to curative surgery or radiation.
d)At least 1 but no more than 3 prior lines of systemic therapy in any setting. Prior endocrine therapy is not counted as a prior line of systemic therapy.
Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Histologically or cytologically confirmed advanced cholangiocarcinoma (intrahepatic, extrahepatic, or hilar). Advanced gallbladder adenocarcinomas are also eligible. Ampullary carcinomas are not eligible in Phase 1b.
b) Unresectable, locally advanced, or metastatic disease.
c) Disease progression during or after at least one prior line of systemic therapy for advanced disease.
d) At least 1 but no more than 3 prior lines of systemic therapy for advanced disease.
Exclusion Criteria:
1. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
2. Participant has received previous treatment with another agent targeting CD24.
3. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Non-epithelial ovarian tumors or ovarian tumors of low malignant potential
4. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Carcinosarcoma histology
5. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Ampullary carcinoma (unless specifically cholangiocarcinoma histology)
b) Gallbladder cancers other than adenocarcinomas.
For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1
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