Advanced Solid TumorPhase 1NCT07128303
Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors
A Phase 1 study testing GS-5319, Carboplatin and Pemetrexed in people with Advanced Solid Tumor, run by Gilead Sciences at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- GS-5319, Carboplatin and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 28 Aug 2025to May 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
12 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
START New Jersey
New Brunswick, New Jersey, 08820
- Recruiting
START San Antonio
San Antonio, Texas, 78229
South Korea4 sites, 4 recruiting
- Recruiting
Yonsei University Severance Hospital
Seoul, '06273
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
Spain3 sites, 3 recruiting
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, 08035
- Recruiting
START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit
Madrid, 28040
- Recruiting
START - Centro Oncológico Clara Campal
Madrid, 28050
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 Monotherapy and Combination Therapy in Adults With MTAP-deleted Advanced Solid Tumors
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).
Read the detailed description
This study includes four arms, Parts A, B, C, and D. Participants in Parts A, B, and D are assigned non-randomized. Participants in Part C are assigned using a randomization procedure.
- Conditions
- Advanced Solid Tumor
- Being tested
- GS-5319, Carboplatin, Pemetrexed, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5319Drug
Administered orally
CarboplatinDrug
Administered intravenously
PemetrexedDrug
Administered intravenously
PembrolizumabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part A: GS-5319 Monotherapy Dose Escalation | Experimental | 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. Receives: Drug: GS-5319 |
| Part B: GS-5319 Monotherapy Dose Expansion | Experimental | Participants will be enrolled based on the selected indications to receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase. Receives: Drug: GS-5319 |
| Part C: GS-5319 Monotherapy Dose Optimization | Experimental | 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. Receives: Drug: GS-5319 |
| Part D: GS-5319 Combination Therapy Dose Escalation | Experimental | 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. Receives: Drug: GS-5319; Drug: Carboplatin; Drug: Pemetrexed; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)
Measured: Up to 2 years
Percentage of Participants Experiencing Laboratory Abnormalities
Measured: Up to 2 years
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Measured: Up to 21 days
Secondary outcomes (6)
Plasma Concentration of GS-5319
Measured: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) parameter: AUC0-last of GS-5319
AUC0-last is the area under the concentration-versus-time curve from time 0 to the time of the last measurable (quantifiable) drug concentration.
Measured: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) parameter: AUC0-inf of GS-5319
AUC0-inf is the area under the concentration-versus-time curve from time 0 extrapolated to infinite time, representing the total drug exposure after administration.
Measured: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) parameter: AUCtau of GS-5319
AUCtau is defined as the area under the concentration-versus-time curve over one dosing interval at steady state.
Measured: Predose and postdose up to end of treatment (up to 2 years)
PK parameter: Cmax of GS-5319
Cmax is defined the maximum observed plasma drug concentration.
Measured: Predose and postdose up to end of treatment (up to 2 years)
PK parameter: Tmax of GS-5319
Tmax is defined as the time to maximum observed concentration.
Measured: Predose and postdose up to end of treatment (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start28 Aug 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128303
- Sponsor's protocol ID
- GS-US-707-7297
- Other IDs
- 2025-522397-36, 2025
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No