Clinical Trial

Study of GS-5319 in Adults With Solid Tumors

Recruiting Phase 1
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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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-08-13; most recent amendment 2026-06-15.
Status change: Not Yet Recruiting → Recruiting 2025-09-03
Trial Details
NCT Number NCT07128303
Lead Sponsor Gilead Sciences
Conditions Advanced Solid Tumor
Enrollment 178 participants
Start Date 2025-08-28
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-17