[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534097":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":31,"locations":37,"responsibleParty":129,"collaborators":131,"id":134,"slug":24,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":24,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":24,"enrollmentInfo":142,"targetDuration":24,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Hanmi Pharmaceutical Company Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BH3120","EXPERIMENTAL","Arm A: BH3120 Monotherapy",[13],"Drug: BH3120",{"label":15,"type":10,"description":16,"interventionNames":17},"BH3120 + pembrolizumab","Arm B: BH3120 in combination with pembrolizumab",[13,18],"Drug: pembrolizumab",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle",[9,15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"pembrolizumab","Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle",[15],[30],"KEYTRUDA®",[32],{"name":33,"role":34,"phone":35,"phoneExt":24,"email":36},"Young Su (Bobby) Noh","CONTACT","82-2-410-9277","63forever@hanmi.co.kr",[38,51,61,71,82,91,102,111,117,123],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Moffitt Cancer Center","RECRUITING","Tampa","Florida","33612","United States",{"type":46,"coordinates":47},"Point",[48,49],-82.45843,27.94752,{"lat":49,"lon":48},{"facility":52,"status":40,"city":53,"state":54,"zip":55,"country":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":24},"The START Center for Cancer Care - Midwest","Grand Rapids","Michigan","49546",{"type":46,"coordinates":57},[58,59],-85.66809,42.96336,{"lat":59,"lon":58},{"facility":62,"status":40,"city":63,"state":64,"zip":65,"country":44,"cosmosGeoPoint":66,"geoPoint":70,"contacts":24},"Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center","Cincinnati","Ohio","45219",{"type":46,"coordinates":67},[68,69],-84.51439,39.12711,{"lat":69,"lon":68},{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":44,"cosmosGeoPoint":77,"geoPoint":81,"contacts":24},"Mary Crowley Cancer Research","WITHDRAWN","Dallas","Texas","75230",{"type":46,"coordinates":78},[79,80],-96.80667,32.78306,{"lat":80,"lon":79},{"facility":83,"status":40,"city":84,"state":75,"zip":85,"country":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":24},"Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center","San Antonio","78229",{"type":46,"coordinates":87},[88,89],-98.49363,29.42412,{"lat":89,"lon":88},{"facility":92,"status":40,"city":93,"state":94,"zip":95,"country":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":24},"Seoul National University Bundang Hospital","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":46,"coordinates":98},[99,100],127.13778,37.43861,{"lat":100,"lon":99},{"facility":103,"status":40,"city":104,"state":24,"zip":105,"country":96,"cosmosGeoPoint":106,"geoPoint":110,"contacts":24},"Seoul National University Hospital","Seoul","03080",{"type":46,"coordinates":107},[108,109],126.9784,37.566,{"lat":109,"lon":108},{"facility":112,"status":40,"city":104,"state":24,"zip":113,"country":96,"cosmosGeoPoint":114,"geoPoint":116,"contacts":24},"Severance Hospital","03722",{"type":46,"coordinates":115},[108,109],{"lat":109,"lon":108},{"facility":118,"status":40,"city":104,"state":24,"zip":119,"country":96,"cosmosGeoPoint":120,"geoPoint":122,"contacts":24},"Asan Medical Center","05505",{"type":46,"coordinates":121},[108,109],{"lat":109,"lon":108},{"facility":124,"status":40,"city":104,"state":24,"zip":125,"country":96,"cosmosGeoPoint":126,"geoPoint":128,"contacts":24},"Samsung Medical Center","06351",{"type":46,"coordinates":127},[108,109],{"lat":109,"lon":108},{"type":130,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[132],{"name":133,"class":6},"Merck Sharp & Dohme LLC","100534097",false,"NCT06234397","Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.\n* PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).\n* Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Age of 18 years or older (or country's legal age of majority if the legal age was \\>18 years)\n* Adequate Hematologic and liver function.\n\nKey Exclusion Criteria:\n\n* Has received prior therapy with an anti-4-1BB(CD137) agent.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* Known additional malignancy that is progressing or has required active treatment.\n* History of chronic liver disease or evidence of hepatic cirrhosis.\n* History of severe toxicities associated with a prior immunotherapy.\n* Has ongoing or suspected autoimmune disease.\n* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.","ALL","18 Years",{"count":143,"type":144},245,"ESTIMATED","INTERVENTIONAL",[147],"PHASE1","This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.",[150],"Advanced or Metastatic Solid Tumors","2026-03-09",{"date":153,"type":154},"2026-03-11","ACTUAL",{"date":156,"type":154},"2023-12-28",{"date":158,"type":144},"2028-01",{"name":5,"class":6},10]