NCT06082960

Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 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: 45 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors * Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	GS-9911	Tablets administered orally
DRUG	Zimberelimab	Administered intravenously

Timeline

• Start date: 2023-10-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-10-13
• Last updated: 2026-04-16

Locations

6 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study