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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

Sponsored by Arcus Biosciences, Inc.

About this trial

Last updated 8 months ago

Study ID

ARC-21

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 3 years ago

What is this trial about?

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).

What are the Participation Requirements?

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.