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Study of GS-5319 in Adults With Solid Tumors
Sponsor: Gilead Sciences
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).
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2025-08-28
Completion Date
2028-05
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
GS-5319
Administered orally
Locations (8)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
START San Antonio
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit
Madrid, Spain
START - Centro Oncológico Clara Campal
Madrid, Spain