[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07160725":3,"trial-entities:NCT07160725":343,"trial-summary:NCT07160725":350},{"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":26,"interventions":29,"primary_outcomes":50,"secondary_outcomes":64,"sex":79,"minimum_age":80,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":95,"locations":98,"central_contacts":325,"overall_officials":332,"references":335,"see_also_links":336},"NCT07160725","CA254-0001","A Phase 1\u002F2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors","A Phase 1\u002F2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors","RECRUITING","2028-08-01","2026-08","2026-08-11","2025-10-15","Bristol-Myers Squibb","INDUSTRY",false,"A phase 1\u002F2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors",null,[19],"Solid Tumours",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},540,"ESTIMATED",[30,43],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","BMS-986517","Specified dose on specified days",[35,36,37,38,39,40,41,42],"Part 1A Monotherapy Dose Escalation","Part 1B Combination Dose Escalation","Part 1C: Monotherapy PD Sub-study","Part 2A: Monotherapy Dose Expansion Cohort A","Part 2A: Monotherapy Dose Expansion Cohort B","Part 2A: Monotherapy Dose Expansion Cohort C","Part 2B: Combination Dose Expansion Cohort A","Part 2B: Combination Dose Expansion Cohort B",{"type":31,"name":44,"description":33,"armGroupLabels":45,"otherNames":46},"Pumitamig",[36,41,42],[47,48,49],"BMS-986545","BNT327","PMS002",[51,54,56,60,62],{"measure":52,"timeFrame":53},"Number of Participants with Adverse Events (AE)","Up to approximately 2 years",{"measure":55,"timeFrame":53},"Number of Participants with Serious Adverse Events (SAE)",{"measure":57,"description":58,"timeFrame":59},"Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria","For part 1 only","Up to Day 21",{"measure":61,"timeFrame":53},"Number of Participants with AEs Leading to Discontinuation",{"measure":63,"timeFrame":53},"Number of Participants with AEs Leading to Deaths",[65,68,70,72,74,76],{"measure":66,"timeFrame":67},"Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment","Up to approximately 3 years",{"measure":69,"timeFrame":67},"Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment",{"measure":71,"timeFrame":53},"Maximum Plasma Concentration (Cmax)",{"measure":73,"timeFrame":53},"Time to Reach Maximum Plasma Concentration (Tmax)",{"measure":75,"timeFrame":53},"Area Under Curve (AUC)",{"measure":77,"timeFrame":78},"Total anti-drug antibodies (ADAs)","Up to approximately 2 Years","ALL","18 Years",{"inclusion":82,"exclusion":86,"raw_text":94},[83,84,85],"Participants must have an ECOG performance status of 0 to 1.","Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).","Participants must have documented histologically or cytologically confirmed advanced, unresectable\u002Fmetastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+\u002FHER2- breast cancer.",[87,88,89,90,91,92,93],"Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).","Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.","Participants must not have history of serious recurrent infections.","Participants must not have impaired cardiac function or history of severe heart disease.","For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.","For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current\u002Fsuspected ILD\u002Fpneumonitis.","For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.","Inclusion Criteria\n\n* Participants must have an ECOG performance status of 0 to 1.\n* Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).\n* Participants must have documented histologically or cytologically confirmed advanced, unresectable\u002Fmetastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+\u002FHER2- breast cancer.\n\nExclusion Criteria\n\n* Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).\n* Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.\n* Participants must not have history of serious recurrent infections.\n* Participants must not have impaired cardiac function or history of severe heart disease.\n* For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.\n* For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current\u002Fsuspected ILD\u002Fpneumonitis.\n* For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",[96,97],"ADULT","OLDER_ADULT",[99,113,124,135,147,159,171,183,195,207,219,232,244,252,262,274,285,295,307,318],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":110},"Local Institution - 0033","NOT_YET_RECRUITING","Irvine","California","92612","United States",[107],{"name":108,"role":109},"Site 0033","CONTACT",{"lat":111,"lon":112},33.66946,-117.82311,{"facility":114,"status":8,"city":115,"state":103,"zip":116,"country":105,"contacts":117,"geoPoint":121},"USC\u002FNorris Comprehensive Cancer Center","Los Angeles","90033",[118],{"name":119,"role":109,"phone":120},"Anthony El-Khoueiry, Site 0002","323-865-3967",{"lat":122,"lon":123},34.05223,-118.24368,{"facility":125,"status":8,"city":126,"state":103,"zip":127,"country":105,"contacts":128,"geoPoint":132},"University of California, Irvine (UCI) Health - UC Irvine Medical Center","Orange","92868-3201",[129],{"name":130,"role":109,"phone":131},"Rupali Nabar, Site 0021","310-222-2222",{"lat":133,"lon":134},33.78779,-117.85311,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":105,"contacts":140,"geoPoint":144},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",[141],{"name":142,"role":109,"phone":143},"Dan Zandberg, Site 0008","412-864-7955",{"lat":145,"lon":146},40.44062,-79.99589,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":105,"contacts":152,"geoPoint":156},"Sanford Cancer Center","Sioux Falls","South Dakota","57104",[153],{"name":154,"role":109,"phone":155},"Steven Powell, Site 0005","605-328-8000",{"lat":157,"lon":158},43.54369,-96.72796,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":105,"contacts":164,"geoPoint":168},"START - Dallas Fort Worth","Fort Worth","Texas","76104",[165],{"name":166,"role":109,"phone":167},"Henry Xiong, Site 0030","682-350-3010",{"lat":169,"lon":170},32.72541,-97.32085,{"facility":172,"status":8,"city":173,"state":162,"zip":174,"country":105,"contacts":175,"geoPoint":180},"START San Antonio","San Antonio","78229",[176],{"name":177,"role":109,"phone":178,"email":179},"Drew Rasco, Site 0020","210-593-5250","hopeteam@startresearch.com",{"lat":181,"lon":182},29.42412,-98.49363,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":105,"contacts":188,"geoPoint":192},"START Mountain Region","West Valley City","Utah","84119",[189],{"name":190,"role":109,"phone":191},"William McKean, Site 0031","801-907-4750",{"lat":193,"lon":194},40.69161,-112.00105,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":105,"contacts":200,"geoPoint":204},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",[201],{"name":202,"role":109,"phone":203},"Lauren Shih, Site 0028","206-606-7763",{"lat":205,"lon":206},47.60621,-122.33207,{"facility":208,"status":101,"city":209,"state":210,"zip":211,"country":212,"contacts":213,"geoPoint":216},"Local Institution - 0034","Guangzhou","Guangdong","510120","China",[214],{"name":215,"role":109},"Site 0034",{"lat":217,"lon":218},23.11667,113.25,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":224,"contacts":225,"geoPoint":229},"Herlev and Gentofte Hospital","Copenhagen","Capital Region","2730","Denmark",[226],{"name":227,"role":109,"phone":228},"Mogens Boisen, Site 0016","+45 38 68 91 25",{"lat":230,"lon":231},55.67594,12.56553,{"facility":233,"status":8,"city":234,"state":235,"zip":236,"country":224,"contacts":237,"geoPoint":241},"Odense Universitetshospital","Odense","Region Syddanmark","5000",[238],{"name":239,"role":109,"phone":240},"Annette Kodahl, Site 0015","+45 21133379",{"lat":242,"lon":243},55.39594,10.38831,{"facility":245,"status":8,"city":221,"zip":246,"country":224,"contacts":247,"geoPoint":251},"Copenhagen University Hospital Rigshospitalet","2100",[248],{"name":249,"role":109,"phone":250},"Kristoffer Rohrberg, Site 0017","+ 45 3545 9540",{"lat":230,"lon":231},{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":257,"contacts":258},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045","Japan",[259],{"name":260,"role":109,"phone":261},"Noboru Yamamoto, Site 0029","81335422511",{"facility":263,"status":101,"city":264,"state":265,"zip":266,"country":267,"contacts":268,"geoPoint":271},"Local Institution - 0026","Málaga","Andalusia","29010","Spain",[269],{"name":270,"role":109},"Site 0026",{"lat":272,"lon":273},36.72016,-4.42034,{"facility":275,"status":101,"city":276,"state":277,"zip":278,"country":267,"contacts":279,"geoPoint":282},"Local Institution - 0022","Badalona","Barcelona [Barcelona]","08916",[280],{"name":281,"role":109},"Site 0022",{"lat":283,"lon":284},41.45004,2.24741,{"facility":286,"status":101,"city":287,"state":277,"zip":288,"country":267,"contacts":289,"geoPoint":292},"Local Institution - 0024","Barcelona","08035",[290],{"name":291,"role":109},"Site 0024",{"lat":293,"lon":294},41.38879,2.15899,{"facility":296,"status":8,"city":297,"state":298,"zip":299,"country":267,"contacts":300,"geoPoint":304},"Clinica Universidad de Navarra","Pamplona","Navarre","31008",[301],{"name":302,"role":109,"phone":303},"Ignacio Melero Bermejo, Site 0025","34948255400",{"lat":305,"lon":306},42.81687,-1.64323,{"facility":308,"status":8,"city":309,"zip":310,"country":267,"contacts":311,"geoPoint":315},"Hospital Universitario Fundación Jiménez Díaz","Madrid","28040",[312],{"name":313,"role":109,"phone":314},"Victor Moreno Garcia, Site 0027","915504800ext2805",{"lat":316,"lon":317},40.4165,-3.70256,{"facility":319,"status":101,"city":309,"zip":320,"country":267,"contacts":321,"geoPoint":324},"Local Institution - 0023","28050",[322],{"name":323,"role":109},"Site 0023",{"lat":316,"lon":317},[326,330],{"name":327,"role":109,"phone":328,"email":329},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":331,"role":109},"First line of the email MUST contain NCT # and Site #.",[333],{"name":13,"affiliation":13,"role":334},"STUDY_DIRECTOR",[],[337,340],{"label":338,"url":339},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":341,"url":342},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT07160725.html",{"nct_id":4,"conditions":344,"biomarkers":349},[345,346,347,348],"Breast Carcinoma","Head and Neck Squamous Cell Carcinoma","Lung Non-Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":351,"summary":352,"prompt_version":362},true,{"design":353,"status":354,"heading":355,"summary":356,"follow_up":357,"word_count":358,"commitments":359,"compensation":360,"drugs_mentioned":361},"This is a Phase 1\u002F2a, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 540 participants.","completed","Phase 1\u002F2a Study of BMS-986517 for Advanced Solid Tumors","This study is testing a new drug called BMS-986517 in people with advanced solid tumors. It's a \"first-in-human\" study, meaning it's one of the first times this drug is being given to people. Researchers want to see how safe BMS-986517 is and what side effects it might cause. Some participants may also receive Pumitamig. You might be able to join if you are 18 or older, have advanced solid tumors that can be measured, and have a good general health status (ECOG performance status of 0 to 1). The main goals are to track any side effects, including serious ones, for up to about two years.","Participants will be monitored for adverse events (side effects) for up to approximately two years.",106,"Not specified in the trial record.","Not stated in the trial record.",[32,44],"v2"]