Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
NCT06532565 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2026-04-21
Summary
The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors.
The primary objectives of this study are:
* To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab 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-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
Conditions
Interventions
- DRUG
-
GS-2121
Tablet 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
- 2024-07-26
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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