[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534097":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":31,"locations":37,"responsibleParty":130,"collaborators":132,"id":135,"slug":24,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":24,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":24,"enrollmentInfo":143,"targetDuration":24,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"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",[38,52,62,72,83,92,103,112,118,124],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"Moffitt Cancer Center","RECRUITING","Tampa","Florida","33612","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-82.45843,27.94752,{"lat":50,"lon":49},{"facility":53,"status":40,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":24},"The START Center for Cancer Care - Midwest","Grand Rapids","Michigan","49546",{"type":47,"coordinates":58},[59,60],-85.66809,42.96336,{"lat":60,"lon":59},{"facility":63,"status":40,"city":64,"state":65,"zip":66,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":71,"contacts":24},"Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center","Cincinnati","Ohio","45219",{"type":47,"coordinates":68},[69,70],-84.51439,39.12711,{"lat":70,"lon":69},{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":44,"countryCode":45,"cosmosGeoPoint":78,"geoPoint":82,"contacts":24},"Mary Crowley Cancer Research","WITHDRAWN","Dallas","Texas","75230",{"type":47,"coordinates":79},[80,81],-96.80667,32.78306,{"lat":81,"lon":80},{"facility":84,"status":40,"city":85,"state":76,"zip":86,"country":44,"countryCode":45,"cosmosGeoPoint":87,"geoPoint":91,"contacts":24},"Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center","San Antonio","78229",{"type":47,"coordinates":88},[89,90],-98.49363,29.42412,{"lat":90,"lon":89},{"facility":93,"status":40,"city":94,"state":95,"zip":96,"country":97,"countryCode":24,"cosmosGeoPoint":98,"geoPoint":102,"contacts":24},"Seoul National University Bundang Hospital","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":47,"coordinates":99},[100,101],127.13778,37.43861,{"lat":101,"lon":100},{"facility":104,"status":40,"city":105,"state":24,"zip":106,"country":97,"countryCode":24,"cosmosGeoPoint":107,"geoPoint":111,"contacts":24},"Seoul National University Hospital","Seoul","03080",{"type":47,"coordinates":108},[109,110],126.9784,37.566,{"lat":110,"lon":109},{"facility":113,"status":40,"city":105,"state":24,"zip":114,"country":97,"countryCode":24,"cosmosGeoPoint":115,"geoPoint":117,"contacts":24},"Severance Hospital","03722",{"type":47,"coordinates":116},[109,110],{"lat":110,"lon":109},{"facility":119,"status":40,"city":105,"state":24,"zip":120,"country":97,"countryCode":24,"cosmosGeoPoint":121,"geoPoint":123,"contacts":24},"Asan Medical Center","05505",{"type":47,"coordinates":122},[109,110],{"lat":110,"lon":109},{"facility":125,"status":40,"city":105,"state":24,"zip":126,"country":97,"countryCode":24,"cosmosGeoPoint":127,"geoPoint":129,"contacts":24},"Samsung Medical Center","06351",{"type":47,"coordinates":128},[109,110],{"lat":110,"lon":109},{"type":131,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[133],{"name":134,"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":144,"type":145},245,"ESTIMATED","INTERVENTIONAL",[148],"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.",[151],"Advanced or Metastatic Solid Tumors","2026-03-09",{"date":154,"type":155},"2026-03-11","ACTUAL",{"date":157,"type":155},"2023-12-28",{"date":159,"type":145},"2028-01",{"name":5,"class":6},10]