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A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

About

Brief Summary

The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
  • Eastern cooperative oncology group (ECOG) Performance Score of 0-1
  • At least one measurable target lesion per RECIST v1.1.
  • Adequate organ and marrow function
  • Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing

Key Exclusion Criteria:

  • Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
  • Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
  • Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
  • Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
  • History of trauma or major surgery within 28 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Study Stats
Protocol No.
22-000840
Category
Colorectal Cancer
Esophageal Cancer
Liver Cancer
Lung Cancer
Pancreatic Cancer
Prostate Cancer
Stomach Cancer
Contact
LISA-MARIA YONEMOTO
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05329766
For detailed technical eligibility, visit ClinicalTrials.gov.