A Phase 2 interventional study of Domvanalimab and Quemliclustat in Gastrointestinal Tract Malignancies, sponsored by Arcus Biosciences, Inc.. Active, not recruiting at 43 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Arcus Biosciences, Inc. · Phase 2, Interventional, and Treatment
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).
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)
Drug: Domvanalimab · Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W
Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W. After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Drug: Domvanalimab · Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion
Drug: Domvanalimab · Drug: Zimberelimab
Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion
Drug: Quemliclustat · Drug: Zimberelimab
Domvanalimab and zimberelimab Q3W administered by IV infusion
Drug: Domvanalimab · Drug: Zimberelimab
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Number of Participants with Adverse Events (AEs)
Time frame: Up to 18 months
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 18 months
Objective Response Rate (ORR) as measured by PD-L1 Expression Level
Time frame: Up to 18 months
Overall survival (OS)
Time frame: From date of first dose until the date of death due to any cause (approximately 18 months)
Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 18 months
Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks
Time frame: Up to 18 months
Duration of response (DOR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 18 months
Plasma concentration of domvanalimab
Time frame: Up to 18 months
Plasma concentration of zimberelimab
Time frame: Up to 18 months
Plasma concentration of quemliclustat
Time frame: Up to 18 months
Percentage of participants with anti-drug antibodies to domvanalimab
Time frame: Up to 18 months
Percentage of participants with anti-drug antibodies to zimberelimab
Time frame: Up to 18 months
Plan to share: Yes — Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Arcus Biosciences, Inc.