Upper GI

Gastrointestinal Cancer
Upper GI
- EGC/ Squamous
  - Local
    - Chemoradiation
    - Surgery
  - Recurrent/Metastatic
    - First Line
    - Beyond First Line
- EGC/ Adenocarcinoma
  - Gastric
    - Local
    - Recurrent/Metatstatic
      - 1L
      - 2L
        
        SWOGGIS2303
        PARAMUNE: 2L Paclit+Ramucir +/- Nivo in Pts w/PD-L1 CPS >/= 1 Adv Gast & Esoph Adenocarcinoma
        
        -Advanced/Metastatic or Locally Unresectable Gastric, GEJ, or Esophageal Adenocarcinoma.
        -PDL1 CPS > 1, MSS, HER2 negative.
        -Disease progression or intolerance to 1L Chemo + Immunotherapy (i.e. FOLFOX/Nivo)
        -Disease progression while on or within 6 months of completing peri-operative chemo + immunotherapy.
        -Cannot have received more than 1L of therapy.
      - Peritoneal only disease
        
        ECOGGIEA2234
        STOPGAP II: Phase II/III Study of IP Paclitaxel + Systemic Tx vs Systemic Tx Alone in Gastric Carc.
  - Esophageal / GEJ
    - Local
    - Recurrent/Metastatic
      - First Line
        
        CLDN Positive
        
        FGFR2b Positive
        
        HER2 Positive
        
        Oligometastatic
        
        Marker agnostic
        
        VICCGI24578
        Phase III 1L Treatment Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer.
        
        Inclusion criteria:
        *With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
        *Has measurable disease as assessed by IRRC according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, the target lesion must not be a bone metastatic lesion only.
        *HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH+, as assessed by a central laboratory on a primary or metastatic tumor.
        *ECOG PS within 7 days before randomization: 0-1.
        *Expected survival >= 6 months.
        
        Exclusion criteria:
        *Subjects with other malignant tumors within 2 years before the randomization. Subjects with localized tumors that have been resolved, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, and thyroid carcinoma, may be enrolled.
        *Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma. Patient may have received prior perioperative therapy(neoadjuvant or adjuvant therapy) as long as it was completed at least 6 months prior to randomization and without progression.
        *Prior use of doxorubicin with in vivo concentrations > 360 mg/m2 (or equivalent); Note: Equivalent drugs include epirubicin > 720 mg/m2 , mitoxantrone > 120 mg/m2 , idarubicin > 90 mg/m2 , liposomal doxorubicin or other anthracycline antibiotics greater than an equivalent of 360 mg/m2 of doxorubicin. If more than one anthracyclines are used, the cumulative dose should not exceed the doxorubicin equivalent dose of 360 mg/m2 .
        *Previous treatment with any HER2-target therapy.
        *Residual toxicity resulting from previous therapy. Alopecia is permitted
      - Beyond First Line
        
        FGFR 2b Positive
        
        HER2 Positive
        
        CLDN Positive
        
        Oligometastatic
        
        Marker agnostic
        
        2L
        
        SWOGGIS2303
        PARAMUNE: 2L Paclit+Ramucir +/- Nivo in Pts w/PD-L1 CPS >/= 1 Adv Gast & Esoph Adenocarcinoma
        
        -Advanced/Metastatic or Locally Unresectable Gastric, GEJ, or Esophageal Adenocarcinoma.
        -PDL1 CPS > 1, MSS, HER2 negative.
        -Disease progression or intolerance to 1L Chemo + Immunotherapy (i.e. FOLFOX/Nivo)
        -Disease progression while on or within 6 months of completing peri-operative chemo + immunotherapy.
        -Cannot have received more than 1L of therapy.
- Phase 1
  - VICCMDP2287
    OL Mltcntr FIH Ph1 Dose-Esc & Mltchrt Exp INBRX-109 Subj w/Loc Adv or Metast Sol Tum Incl Sarcomas
    - 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
  - VICC-NTPHI23420
    Phase I trial of ZEN003694 in Combination with Capecitabine in Solid Tumors
    - 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