Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Start Date
8/18/2021
Completion Date
12/1/2028
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.
Detailed Description
Part D allocation for 1 cohort will be randomized.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Denikitug
Zimberelimab
Conditions
Locations
University of California San Diego
La Jolla, California 92093
United States
Stanford Cancer Center
Palo Alto, California 94305
United States
Smilow Cancer Center
New Haven, Connecticut 06510
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
University of Texas Southwestern Medical Center
Dallas, Texas 39090
United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas 75230
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology
San Antonio, Texas 78229
United States
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin 53705
United States
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Monash Medical Centre
Clayton, Victoria 3168
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
University Health Network, Princess Margaret Cancer Centre
Toronto, M5G 2M9
Canada
Hospital Universitari Vall d´Hebrón
Barcelona, 08035
Spain
MD Anderson Cancer Center
Madrid, 28033
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario Quironsalud Madrid
Madrid, 28223
Spain
Clinica Universidad de Navarra
Pamplona, 31008
Spain
Changhua Christian Hospital
Changhua, 500
Taiwan
Chi Mei Hospital, Liouying
Tainan, 73657
Taiwan
National Taiwan University Cancer Center (NTUCC)
Taipei, 100229
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Taipei Tzu Chi General Hospital
Taipei, 110
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 33308
Taiwan