[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07128303":3,"trial-entities:NCT07128303":184,"trial-summary:NCT07128303":189},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":57,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":97,"locations":100,"central_contacts":169,"overall_officials":175,"references":179,"see_also_links":180},"NCT07128303","GS-US-707-7297","Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors","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","RECRUITING","2028-05","2026-08","2026-08-19","2025-08-28","Gilead Sciences","INDUSTRY",false,"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.\n\nThe 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)\u002Fmaximum administered dose (MAD) and\u002For the recommended dose(s) for expansion (RDE).","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.",[19],"Advanced Solid Tumor",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},476,"ESTIMATED",[29,38,42,45],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","GS-5319","Administered orally",[34,35,36,37],"Part A: GS-5319 Monotherapy Dose Escalation","Part B: GS-5319 Monotherapy Dose Expansion","Part C: GS-5319 Monotherapy Dose Optimization","Part D: GS-5319 Combination Therapy Dose Escalation",{"type":30,"name":39,"description":40,"armGroupLabels":41},"Carboplatin","Administered intravenously",[37],{"type":30,"name":43,"description":40,"armGroupLabels":44},"Pemetrexed",[37],{"type":30,"name":46,"description":40,"armGroupLabels":47},"Pembrolizumab",[37],[49,52,54],{"measure":50,"timeFrame":51},"Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)","Up to 2 years",{"measure":53,"timeFrame":51},"Percentage of Participants Experiencing Laboratory Abnormalities",{"measure":55,"timeFrame":56},"Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts","Up to 21 days",[58,61,64,67,70,73],{"measure":59,"timeFrame":60},"Plasma Concentration of GS-5319","Predose and postdose up to end of treatment (up to 2 years)",{"measure":62,"description":63,"timeFrame":60},"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.",{"measure":65,"description":66,"timeFrame":60},"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.",{"measure":68,"description":69,"timeFrame":60},"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.",{"measure":71,"description":72,"timeFrame":60},"PK parameter: Cmax of GS-5319","Cmax is defined the maximum observed plasma drug concentration.",{"measure":74,"description":75,"timeFrame":60},"PK parameter: Tmax of GS-5319","Tmax is defined as the time to maximum observed concentration.","ALL","18 Years",null,{"inclusion":80,"exclusion":88,"raw_text":96},[81,82,83,84,85,86,87],"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",[89,90,91,92,93,94,95],"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\u002For requiring medical intervention.","Active human immunodeficiency virus (HIV)\u002Fhepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) infection","Key Inclusion Criteria:\n\n* 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).\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Adequate organ function\n* Age ≥ 18yrs old ( ≥ 19 years old for patients in South Korea)\n* Participants must meet the following tissue requirements:\n\n  * pretreatment tumor tissue is required\n\nKey Exclusion Criteria:\n\n* 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.\n* Positive serum pregnancy test or participant who is breastfeeding.\n* Requirement for ongoing therapy with any prohibited medications.\n* Have not recovered (ie, returned to Grade 1 or baseline) from adverse events (AEs) due to a previously administered agent.\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.\n* Ascites or pleural effusion that is symptomatic and\u002For requiring medical intervention.\n* Active human immunodeficiency virus (HIV)\u002Fhepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) infection\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",[98,99],"ADULT","OLDER_ADULT",[101,110,114,122,130,138,142,146,150,158,165],{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":106,"geoPoint":107},"Massachusetts General Hospital","Boston","Massachusetts","02114","United States",{"lat":108,"lon":109},42.35843,-71.05977,{"facility":111,"status":8,"city":103,"state":104,"zip":112,"country":106,"geoPoint":113},"Beth Israel Deaconess Medical Center","02215",{"lat":108,"lon":109},{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":106,"geoPoint":119},"START San Antonio","San Antonio","Texas","78229",{"lat":120,"lon":121},29.42412,-98.49363,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":106,"geoPoint":127},"NEXT Virginia","Fairfax","Virginia","22031",{"lat":128,"lon":129},38.84622,-77.30637,{"facility":131,"status":8,"city":132,"zip":133,"country":134,"geoPoint":135},"Yonsei University Severance Hospital","Seoul","'06273","South Korea",{"lat":136,"lon":137},37.566,126.9784,{"facility":139,"status":8,"city":132,"zip":140,"country":134,"geoPoint":141},"Seoul National University Hospital","03080",{"lat":136,"lon":137},{"facility":143,"status":8,"city":132,"zip":144,"country":134,"geoPoint":145},"Asan Medical Center","05505",{"lat":136,"lon":137},{"facility":147,"status":8,"city":132,"zip":148,"country":134,"geoPoint":149},"Samsung Medical Center","06351",{"lat":136,"lon":137},{"facility":151,"status":8,"city":152,"zip":153,"country":154,"geoPoint":155},"Vall d'Hebron Institute of Oncology (VHIO)","Barcelona","08035","Spain",{"lat":156,"lon":157},41.38879,2.15899,{"facility":159,"status":8,"city":160,"zip":161,"country":154,"geoPoint":162},"START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit","Madrid","28040",{"lat":163,"lon":164},40.4165,-3.70256,{"facility":166,"status":8,"city":160,"zip":167,"country":154,"geoPoint":168},"START - Centro Oncológico Clara Campal","28050",{"lat":163,"lon":164},[170],{"name":171,"role":172,"phone":173,"email":174},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[176],{"name":177,"affiliation":13,"role":178},"Gilead Study Director","STUDY_DIRECTOR",[],[181],{"label":182,"url":183},"Gilead Clinical Trials Website","https:\u002F\u002Fwww.gileadclinicaltrials.com\u002Fstudy?nctid=NCT07128303",{"nct_id":4,"conditions":185,"biomarkers":187},[186],"Solid Neoplasm",[188],"MTAP Gene",{"nct_id":4,"found":190,"summary":191,"prompt_version":201},true,{"design":192,"status":193,"heading":194,"summary":195,"follow_up":196,"word_count":197,"commitments":198,"compensation":199,"drugs_mentioned":200},"This is an interventional study, meaning participants will receive the study drug GS-5319. It aims to enroll 178 participants.","completed","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.","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.",93,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]