RecruitingPhase 2NCT07527858

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)


Sponsor

Gilead Sciences

Enrollment

170 participants

Start Date

May 19, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Denikitug, and others for people with advanced microsatellite stable colorectal cancer. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDenikitug

Administered Intravenously

DRUGNivolumab

Administered Intravenously

DRUGBevacizumab

Administered Intravenously

DRUGTrifluridine-Tipiracil

Administered orally


Locations(14)

Yale-New Haven Hospital - Yale Cancer Center

North Haven, Connecticut, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

University of Virginia,

Charlottesville, Virginia, United States

Chris O'Brien Lifehouse

Camperdown, CA, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Samsung Medical Center

Busan, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei University Severance Hospital ( aka Yonsei Cancer Center)

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital General Universitario Gregorio Maranon

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07527858