NCT06532565

Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (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-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

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GS-2121	Tablet administered orally
DRUG	Zimberelimab	Administered intravenously

Timeline

• Start date: 2024-07-26
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-08-01
• Last updated: 2025-05-16

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study