drugset / Trial / NCT07527858

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

NCT07527858

Phase 2 Recruiting 170 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2026-05-19
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody Intravenous
Subject Denikitug Monoclonal antibody Intravenous
Subject Nivolumab Monoclonal antibody Intravenous
Subject TAS-102 Small molecule Oral

Indications