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RECRUITING
NCT05007782
PHASE1

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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

Interventions

DRUG

Denikitug

Administered Intravenously

DRUG

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