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ACTIVE NOT RECRUITING
NCT05840224
PHASE1

Study of GS-4528 in Adults With Solid Tumors

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

Summary

The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody. The primary objectives of this study are: * To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.

Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 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

182

Start Date

2023-05-11

Completion Date

2026-07

Last Updated

2026-01-28

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

GS-4528

Administered intravenously

DRUG

Zimberelimab

Administered intravenously.

Locations (16)

The University of Washington/FHCC

Seattle, Washington, United States

The Ottawa Hospital

Ottawa, Canada

University Health Network, Princess Margaret Cancer Centre

Toronto, Canada

Asan Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health Systems

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1

Barcelona, Spain

Hospital Universitari Vall D'Hebron- Oncology Service

Barcelona, Spain

START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I

Madrid, Spain

START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I

Madrid, Spain

Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos

Pamplona, Spain

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation

Taoyuan District, Taiwan

St Bartholomew's Hospital

London, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom