Recruiting
Phase 1

GS-5319

Sponsor:

Gilead Sciences

Code:

NCT07128303

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GS-5319

Carboplatin

Pemetrexed

Pembrolizumab

Study Details

Brief 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).

Conditions

Advanced Solid Tumor

Study ID

NCT07128303

Start date

Aug 28, 2025

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

476 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: GS-5319 Monotherapy Dose Escalation

Participants will receive escalating doses of GS-5319 monotherapy, until disease progression, or until the participants meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first to determine the recommended dose for dose expansion phase.

experimental: Part B: GS-5319 Monotherapy Dose Expansion

Participants will be enrolled based on the selected indications to receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase.

experimental: Part C: GS-5319 Monotherapy Dose Optimization

Participants will be randomized based on the selected indications to receive GS-5319 monotherapy at one of the recommended doses during the monotherapy dose optimization phase.

experimental: Part D: GS-5319 Combination Therapy Dose Escalation

Participants will receive escalating doses of GS-5319 as combination therapy with carboplatin, pemetrexed, pembrolizumab, until disease progression, or until the participants meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first to determine the recommended dose for dose escalation phase.

Interventions

GS-5319

Administered orally

Carboplatin

Administered intravenously

Pemetrexed

Administered intravenously

Pembrolizumab

Administered intravenously

Primary outcome measure

  • Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs) [ Time Frame: Up to 2 years ]
  • Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: Up to 2 years ]
  • Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts [ Time Frame: Up to 21 days ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Gilead Sciences

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-08-19.