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Study of GS-5319 in Adults With Solid Tumors
NCT07128303 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG GS-5319
Study Locations (8)
Other
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- Vall d'Hebron Institute of Oncology (VHIO) — Barcelona
- START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit — Madrid
- START - Centro Oncológico Clara Campal — Madrid
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Texas
- START San Antonio — San Antonio
Virginia
- NEXT Virginia — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2025-08-28 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07128303
The ClinicalTrials.gov registry entry for NCT07128303 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which GS-5319 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07128303 reports 8 study locations spanning 4 distinct geographic areas — top geographies include Other, Massachusetts, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07128303 about?
NCT07128303 is a clinical study titled "Study of GS-5319 in Adults With Solid Tumors". 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 he...
What is the current status of trial NCT07128303?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 178 participants. The study started on 2025-08-28. Estimated completion is 2028-05.
What conditions does trial NCT07128303 study?
This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07128303?
The interventions under investigation include: GS-5319 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07128303?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07128303 being conducted?
This trial has 8 study locations across Massachusetts, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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