Clinical Trial

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

Recruiting Phase 2
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Summary
The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC). The primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).
Protocol Amendment History 4 changes
notable Trial sites expanded: 8 -> 14 locations 2026-07-29
notable Trial sites expanded: 5 -> 8 locations 2026-07-02
critical Recruitment opened 2026-06-13
notable Trial sites expanded: 0 -> 5 locations 2026-06-13
Trial Details
NCT Number NCT07527858
Lead Sponsor Gilead Sciences
Conditions Advanced Microsatellite Stable Colorectal Cancer
Enrollment 170 participants
Start Date 2026-05-19
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-28