A Safety and Efficacy Study of Domvanalimab + Zimberelimab Combination Therapy in Participants With Advanced Upper Gastrointestinal Tract Malignancies

• Status: Not yet recruiting
• Trial end date: 2024-05-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of the anti-T cell immunoglobulin and ITIM domain (TIGIT) monoclonal antibody domvanalimab, the anti-programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy in the first-line setting, and of domvanalimab and zimberelimab in the second-line or greater setting in participants with locally advanced unresectable or metastatic esophageal, gastroesophageal junction (GEJ), and gastric adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcus Biosciences, Inc.
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic esophageal, GEJ, or gastric 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

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 symptomatic, actively progressing, or untreated CNS (brain or leptomeningeal) metastases.

• 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.

• Use of any live vaccines against infectious diseases within 28 days prior to enrollment.