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Recruiting Phase 1

Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors

NCT07128303 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2025-08-28
Last updated
2026-08-19

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

GS-5319Carboplatin →Pemetrexed →Pembrolizumab →

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

Sex
ALL
Min age
18 Years
Max age
—
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 of 0 to 1. * Adequate organ function * Age ≥ 18yrs old ( ≥ 19 years old for patients in South Korea) * Participants must meet the following tissue requirements: * pretreatment tumor tissue is required Key Exclusion Criteria: * Active second malignancy. Participants with a history of malignancy who have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence may be enrolled. * Positive serum pregnancy test or participant who is breastfeeding. * Requirement for ongoing therapy with any prohibited medications. * Have not recovered (ie, returned to Grade 1 or baseline) from adverse events (AEs) due to a previously administered agent. * Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively. * Ascites or pleural effusion that is symptomatic and/or requiring medical intervention. * Active human immunodeficiency virus (HIV)/hepatitis B virus (HBV)/hepatitis C virus (HCV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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)

FacilityCityRegionStatus
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
Official registry record

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