Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
NCT06082960 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-04-16
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
Interventions
- DRUG
-
GS-9911
Tablets administered orally
- DRUG
-
Zimberelimab
Administered intravenously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-09
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
Study Locations
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