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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• START New Jersey
  New Brunswick, New Jersey, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting
• Yonsei University Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.