Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 2 Trial to Evaluate the Safety and Efficacy of Domvanalimab (AB154) and Zimberelimab (AB122) -Based Treatment Combinations in Patients With Advanced Upper Gastrointestinal Tract Malignancies

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

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 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.

Locations

  • UCLA accepting new patients
    Santa Monica California 90024 United States
  • Mayo Clinic accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
ID
NCT05329766
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated