NCT05329766

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-06-10
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2022-04-15
• Last updated: 2026-03-30

Locations

49 sites across 6 countries: United States, Canada, Chile, France, Serbia, South Korea

Regulatory

• FDA-regulated drug study