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Study of GS-4528 in Adults With Solid Tumors
Sponsor: Gilead Sciences
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
GS-4528
Administered intravenously
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