A Phase 1, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants With Advanced MTAP-Deleted Solid Tumors
Gilead Sciences
Summary
The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors. The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Participants 18 years of age or older (≥ 19 years old for participants in South Korea). * Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options. * Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * All participants must provide a pretreatment tumor tissue sample. Key Exclusion Criteria: * Participants wi…
Interventions
- DrugGS-2426
Administered Orally
Locations (2)
- START Astera, LLCEast Brunswick, New Jersey
- START San Antonio, LLCSan Antonio, Texas