Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Start Date
5/19/2026
Completion Date
12/1/2028
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 Criteria
Age Range: 18 years to No maximum
Interventions
Denikitug
Nivolumab
Bevacizumab
Trifluridine-Tipiracil
Conditions
Locations
Yale-New Haven Hospital - Yale Cancer Center
North Haven, Connecticut 06473 2195
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
University of Virginia,
Charlottesville, Virginia 22908
United States
Chris O'Brien Lifehouse
Camperdown, CA 2050
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland 4029
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Samsung Medical Center
Busan, 48775
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Yonsei University Severance Hospital ( aka Yonsei Cancer Center)
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 138-736
South Korea
Hospital General Universitario Gregorio Maranon
Madrid, 28050
Spain