NCT05840224

Study of GS-4528 in Adults With Solid Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	GS-4528	Administered intravenously
DRUG	Zimberelimab	Administered intravenously.

Timeline

• Start date: 2023-05-11
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-05-03
• Last updated: 2026-01-28

Locations

16 sites across 6 countries: United States, Canada, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study