Status:
ACTIVE_NOT_RECRUITING
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Lead Sponsor:
Arcus Biosciences, Inc.
Collaborating Sponsors:
Gilead Sciences
Conditions:
Gastrointestinal Tract Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 meta...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT05329766
Start Date
June 10 2022
End Date
June 1 2027
Last Update
December 31 2025
Active Locations (49)
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1
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Ronald Reagan UCLA Medical Center
Santa Monica, California, United States, 90024
4
Yale Cancer Center
Derby, Connecticut, United States, 06418