Lung

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

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

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

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

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