Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around

Description

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).

Official Title

A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

Keywords

Gastrointestinal Tract Malignancies, Domvanalimab, Quemliclustat, Zimberelimab, Esophageal adenocarcinoma, Gastric adenocarcinoma, Gastric cancer, Gastroesophageal junction cancer, Anti-PD-1 antibody, Anti-CD73, anti-TIGIT antibody, Neoplasms, Leucovorin, Oxaliplatin, Fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • Ronald Reagan UCLA Medical Center accepting new patients
    Santa Monica California 90024 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
Links
ARC-21 - Public website Sign up for this study
ID
NCT05329766
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated