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Brief Title: Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of 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
Study ID: NCT05007782
Brief 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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Mary Crowley Cancer Research, 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
University Health Network, Princess Margaret Cancer Centre, Toronto, , Canada
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 City, , Taiwan
Taipei Tzu Chi General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital, Taoyuan City, , Taiwan
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR