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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

NCT05329766 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2026-04-29

No results posted yet for this study

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).

Conditions

  • Gastrointestinal Tract Malignancies

Interventions

DRUG

Domvanalimab

Administered as specified in the treatment arm

DRUG

Quemliclustat

Administered as specified in the treatment arm

DRUG

Zimberelimab

Administered as specified in the treatment arm

DRUG

Fluorouracil

Administered as specified in the treatment arm

DRUG

Leucovorin

Administered as specified in the treatment arm

DRUG

Oxaliplatin

Administered as specified in the treatment arm

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Arcus Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Arcus Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2027-01-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Chile
  • France
  • Serbia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329766 on ClinicalTrials.gov