Study of GS-5319 in Adults With Solid Tumors
Start Date
8/28/2025
Completion Date
5/1/2028
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
GS-5319
Conditions
Locations
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
START San Antonio
San Antonio, Texas 78229
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Yonsei University Severance Hospital
Seoul, '06273
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, 08035
Spain
START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit
Madrid, 28040
Spain
START - Centro Oncológico Clara Campal
Madrid, 28050
Spain