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Clinical Trials in South Korea / NCT05329766
Active, not recruiting Phase 2

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

NCT05329766 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2022-06-10
Last updated
2026-08-31

Condition(s) studied

Gastrointestinal Tract Malignancies

Investigational drug(s) / intervention(s)

Domvanalimab →Quemliclustat →Zimberelimab →Fluorouracil →Leucovorin →Oxaliplatin →

Domvanalimab: Administered as specified in the treatment arm

Quemliclustat: Administered as specified in the treatment arm

Zimberelimab: Administered as specified in the treatment arm

Fluorouracil: Administered as specified in the treatment arm

Leucovorin: Administered as specified in the treatment arm

Oxaliplatin: Administered as specified in the treatment arm

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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 Key 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 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.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Los Angeles California
Research Site Santa Monica California
Research Site Derby Connecticut
Research Site Fort Myers Florida
Research Site Jacksonville Florida
Research Site St. Petersburg Florida
Research Site Boston Massachusetts
Research Site New York New York
Research Site New York New York
Research Site Durham North Carolina
Research Site Columbus Ohio
Research Site Oklahoma City Oklahoma
Research Site Nashville Tennessee
Research Site Nashville Tennessee
Research Site Fairfax Virginia
Research Site Toronto Canada
Research Site Las Condes Chile
Research Site Recoleta Chile
Research Site Santiago Chile
Research Site Talca Chile
Research Site Bordeaux France
Research Site Brest France
Research Site Caen France
Research Site Lille France
Research Site Lyon France
Research Site Marseille France
Research Site Montpellier France
Research Site Plérin France
Research Site Poitiers France
Research Site Rouen France
Research Site Toulouse France
Research Site Villejuif France
Research Site Belgrade Serbia
Research Site Kamenitz Serbia
Research Site Kragujevac Serbia
Research Site Busan South Korea
Research Site Daegu South Korea
Research Site Hwasun South Korea
Research Site Seongnam-si South Korea

+ 2 more sites — see the full list on the official registry below.

More Arcus Biosciences, Inc. trials in South Korea

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05329766 on ClinicalTrials.gov ↗ ← All trials in South Korea