Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
GS-5319: Administered orally
Carboplatin: Administered intravenously
Pemetrexed: Administered intravenously
Pembrolizumab: Administered intravenously
Study summary
The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability when given as a single medication and as a combined medication 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 as monotherapy and combination therapy in participants with MTAP-deleted advanced solid tumors and identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended dose(s) for expansion (RDE).
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs) — Up to 2 years
- Percentage of Participants Experiencing Laboratory Abnormalities — Up to 2 years
- Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts — Up to 21 days
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| START San Antonio | San Antonio | Texas | Recruiting |
| NEXT Virginia | Fairfax | Virginia | Recruiting |
| Yonsei University Severance Hospital | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Vall d'Hebron Institute of Oncology (VHIO) | Barcelona | Spain | Recruiting |
| START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit | Madrid | Spain | Recruiting |
| START - Centro Oncológico Clara Campal | Madrid | Spain | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07128303 on ClinicalTrials.gov ↗ ← All trials in Spain