A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Participants diagnosed with histologically or cytologically confirmed solid tumor types who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy in the advanced setting (locally-advanced or metastatic). * Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. Deoxyribonucleic acid (DNA) sequencing may be assessed locally such as by local next-generation sequencing (NGS) or by central laboratory assay when available. * Eastern Cooperative Oncology Group (ECOG) performance status score…
Interventions
- DrugGS-5319
Administered orally
Locations (8)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- START San AntonioSan Antonio, Texas
- NEXT VirginiaFairfax, Virginia
- Asan Medical CenterSeoul
- Samsung Medical CenterSeoul
- Vall d'Hebron Institute of Oncology (VHIO)Barcelona