Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT05007782
- Run by
- Gilead Sciences
- People needed
- 416
- Starts
- 2021-08-18
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-12-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (enrolling)
- Stanford Cancer Center — Palo Alto, California, United States (enrolling)
- Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
- University of California San Diego — La Jolla, California, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Sarah Cannon Research Institute at Mary Crowley — Dallas, Texas, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- NEXT Oncology — San Antonio, Texas, United States (enrolling)
- University of Wisconsin Clinical Sciences Center — Madison, Wisconsin, United States (enrolling)
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
- Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
- University Health Network, Princess Margaret Cancer Centre — Toronto, Canada (enrolling)
- Hospital Universitari Vall d´Hebrón — Barcelona, Spain (enrolling)
- MD Anderson Cancer Center — Madrid, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Hospital Universitario Quironsalud Madrid — Madrid, Spain (enrolling)
- Clinica Universidad de Navarra — Pamplona, Spain (enrolling)
- Changhua Christian Hospital — Changhua, Taiwan (enrolling)
- Chi Mei Hospital, Liouying — Tainan, Taiwan (enrolling)
- National Taiwan University Cancer Center (NTUCC) — Taipei, Taiwan (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
- Smilow Cancer Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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