Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Sponsor: Gilead Sciences
Summary
This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors. This study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
416
Start Date
2021-08-18
Completion Date
2028-12
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
Denikitug
Administered Intravenously
Zimberelimab
Administered Intravenously
Locations (26)
University of California San Diego
La Jolla, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Smilow Cancer Center
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada
Hospital Universitari Vall d´Hebrón
Barcelona, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Quironsalud Madrid
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Changhua Christian Hospital
Changhua, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Taiwan University Cancer Center (NTUCC)
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Tzu Chi General Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan