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Study of GS-5319 for Advanced Solid Tumors

This study is looking at a drug called GS-5319 in adults with advanced solid tumors. These are cancers that have spread or can't be treated with standard methods. To join, your tumor must have a specific change where it's missing an enzyme called MTAP (methylthioadenosine phosphorylase), which helps cells grow normally. The main goals are to understand how safe GS-5319 is, what side effects it might cause, and to find the best dose. Researchers will track side effects and lab changes for up to 105 weeks. The study plans to enroll 178 participants.

Study design
This is an interventional study, meaning participants will receive the study drug GS-5319. It aims to enroll 178 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and laboratory abnormalities for up to 30 days after their last dose, which could be up to 105 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07128303

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Gilead Sciences
~476 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:GS-5319CarboplatinPemetrexedPembrolizumab

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)
Measured over Up to 2 years
+2 more outcomes measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid NeoplasmMTAP Gene

Where it's being run

11 sites across 5 states
South Korea4
Spain3
Massachusetts2
Texas1
Virginia1

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)Up to 2 years
  • Percentage of Participants Experiencing Laboratory AbnormalitiesUp to 2 years
  • Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation CohortsUp to 21 days