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Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
Sponsor: Gilead Sciences
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-10-09
Completion Date
2026-11
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
GS-9911
Tablets administered orally
Zimberelimab
Administered intravenously
Locations (6)
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada