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

Sponsor: Arcus Biosciences, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05329766

This study assesses the safety and efficacy of various treatment combinations, including Domvanalimab, Quemliclustat, Zimberelimab, and FOLFOX chemotherapy, in adults with advanced gastric, GEJ, or esophageal adenocarcinoma. Eligible participants must have a life expectancy of ≥3 months, ECOG 0-1, and measurable lesions. Exclusions include HER-2 positive tumors and untreated brain metastases.

Patient Parameters

Program Overview

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).

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic - Arizona85054PhoenixArizona
USC/Norris Comprehensive Cancer Center90033Los AngelesCalifornia
Ronald Reagan UCLA Medical Center90024Santa MonicaCalifornia
Yale Cancer Center06418DerbyConnecticut
Florida Cancer Specialist - South33901Fort MyersFlorida
Mayo Clinic - Jacksonville32224JacksonvilleFlorida
Florida Cancer Specialist - North33705Saint PetersburgFlorida
Massachusetts General Hospital02109BostonMassachusetts
Memorial Sloan Kettering Cancer Center10021-0005New YorkNew York
Columbia University10032New YorkNew York

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