GS-5319 for adults with MTAP-deficient advanced solid tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors

This trial will test GS-5319 to find a safe dose and see if it is tolerated by adults whose advanced solid tumors lack the MTAP gene.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Locations: 8 sites (Boston, Massachusetts and 7 other locations)
• Trial ID: NCT07128303 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label dose‑finding trial gives GS-5319 to adults with advanced solid tumors that are MTAP‑deficient to characterize safety, tolerability, and dosing. Participants must have progressed on or been ineligible for standard therapies and provide pretreatment tumor tissue for MTAP status confirmation by local or central DNA sequencing. The study will use a dose‑escalation design to identify the maximum tolerated/administrable dose (MTD/MAD) and the recommended dose for expansion (RDE). Gilead Sciences sponsors the trial and it is being conducted at multiple U.S. clinical research sites.

Who should consider this trial

Good fit: Adults (≥18 years old, ≥19 in South Korea) with histologically or cytologically confirmed advanced solid tumors that are MTAP‑deficient, who have progressed on or are ineligible for standard therapy, have ECOG 0–1, adequate organ function, and can provide required pretreatment tumor tissue are ideal candidates.

Not a fit: Patients whose tumors are not MTAP‑deleted, who have active second malignancies, poor performance status, or inadequate organ function are unlikely to benefit from this Phase 1 dosing study.

Why it matters

Potential benefit: If successful, GS-5319 could become a new targeted option for patients with MTAP‑deleted advanced solid tumors and establish a safe dose for later trials.

How similar studies have performed: This follows an early MTAP‑targeted drug development approach similar to other first‑in‑human dose‑finding programs, an emerging area with limited published large‑scale clinical success to date.

Eligibility criteria

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:

  1. Part A and B: 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.

Where this trial is running

Boston, Massachusetts and 7 other locations

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• START San Antonio — San Antonio, Texas, United States (Recruiting)
• NEXT Virginia — Fairfax, Virginia, United States (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)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions Advanced Solid Tumor