A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors
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).
Arms & interventions
- DrugGS-5319
Administered orally
Outcome measures
Primary
Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)
Time frame: First Dose up to 30 days post last dose (Up to 105 weeks)
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: First Dose up to 30 days post last dose (Up to 105 weeks)
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Time frame: Up to 21 days
Secondary
Plasma Concentration of GS-5319
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) parameter: AUC0-24 of GS-5319
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK parameter: Cmax of GS-5319
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK parameter: Tmax of GS-5319
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Eligibility criteria
Study locations (3)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
START San Antonio
San Antonio, Texas, 78229
NEXT Virginia
Fairfax, Virginia, 22031