NCT07128303

Study of GS-5319 in Adults With Solid Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability in adults with solid tumors, where the participants show a specific gene alteration in the tumor. The gene helps produce methylthioadenosine phosphorylase (MTAP) enzyme. MTAP enzyme helps in normal growth of cells. The primary objectives of the study are to assess the safety and tolerability of GS-5319 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors and to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended dose for expansion (RDE).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	GS-5319	Administered orally

Timeline

• Start date: 2025-08-28
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-08-17
• Last updated: 2026-03-19

Locations

8 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study