NCT07527858

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

A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Microsatellite Stable Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Denikitug	Administered Intravenously
DRUG	Nivolumab	Administered Intravenously
DRUG	Bevacizumab	Administered Intravenously
DRUG	Trifluridine-Tipiracil	Administered orally

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Regulatory

• FDA-regulated drug study