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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Gilead Sciences
Study ID
NCT07128303
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GS-5319 — DRUG
    Administered orally
  • Carboplatin — DRUG
    Administered intravenously
  • Pemetrexed — DRUG
    Administered intravenously
  • Pembrolizumab — DRUG
    Administered intravenously

Study Details

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).

Key Dates

First listed
Aug 17, 2025
Start date
Aug 28, 2025
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
476 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
START San AntonioSan AntonioTexas78229-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MASTART San Antonio· San Antonio, TXNEXT Virginia· Fairfax, VA

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