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USClinicalTrials.govClinical trialPhase 2Active, not recruiting

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

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Official record

Identifier
NCT05329766
Recruiting locations

countries

United StatesCanadaChileFranceSerbiaSouth Korea
Interventions studied
DomvanalimabQuemliclustatZimberelimabFluorouracilLeucovorinOxaliplatin
Lead sponsor
Arcus Biosciences, Inc.
Target enrolment
332 participants
Study type
INTERVENTIONAL
Phase
Phase 2
Status
Active, not recruiting
First posted
Apr 15, 2022
Last updated on the registry
Sep 29, 2026
Age
18 Years
Sex
ALL
Study contact
No public contact is listed on the official record.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.
Indexed under
Gastric Cancer