> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-gs-5319-given-alone-or-in-combination-in-adults-feac13f0-0a6d-4ffd-93a4-2403adfa0ea8 > Record changed: 2026-10-13 # Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors NCT07128303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) Participants 476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) Start date 2025-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Short title** Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Dates **Completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **First posted** 2025-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Primary completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Start date** 2025-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Size and sites **Participants** 476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Planned participants** 476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Identifiers **Registry ID** NCT07128303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **ClinicalTrials.gov ID** NCT07128303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Outcomes ### Primary outcomes 1. Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs) Timeframe: Up to 2 years 2. Percentage of Participants Experiencing Laboratory Abnormalities Timeframe: Up to 2 years 3. Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts Timeframe: Up to 21 days ### Secondary outcomes 1. Plasma Concentration of GS-5319 Timeframe: Predose and postdose up to end of treatment (up to 2 years) 2. Pharmacokinetic (PK) parameter: AUC0-last of GS-5319 Timeframe: Predose and postdose up to end of treatment (up to 2 years) AUC0-last is the area under the concentration-versus-time curve from time 0 to the time of the last measurable (quantifiable) drug concentration. 3. Pharmacokinetic (PK) parameter: AUC0-inf of GS-5319 Timeframe: Predose and postdose up to end of treatment (up to 2 years) 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. 4. Pharmacokinetic (PK) parameter: AUCtau of GS-5319 Timeframe: Predose and postdose up to end of treatment (up to 2 years) AUCtau is defined as the area under the concentration-versus-time curve over one dosing interval at steady state. 5. PK parameter: Cmax of GS-5319 Timeframe: Predose and postdose up to end of treatment (up to 2 years) Cmax is defined the maximum observed plasma drug concentration. 6. PK parameter: Tmax of GS-5319 Timeframe: Predose and postdose up to end of treatment (up to 2 years) Tmax is defined as the time to maximum observed concentration. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Sites - Massachusetts General HospitalBoston, United StatesRecruiting - Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting - START San AntonioSan Antonio, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - Yonsei University Severance HospitalSeoul, South KoreaRecruiting - Seoul National University HospitalSeoul, South KoreaRecruiting - Asan Medical CenterSeoul, South KoreaRecruiting - Samsung Medical CenterSeoul, South KoreaRecruiting - Vall d'Hebron Institute of Oncology (VHIO)Barcelona, SpainRecruiting - START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials UnitMadrid, SpainRecruiting - START - Centro Oncológico Clara CampalMadrid, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## References - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study?nctid=NCT07128303) ### Other registry identifiers (2) - 2025 - 2025-522397-36 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128303) ## Related records ### Drugs (3) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) ### Targets (4) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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