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Spots Global Cancer Trial Database for Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

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Trial Identification

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

Interventions

GS-1811
Zimberelimab

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gilead Study Director

Affiliation: Gilead Sciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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