[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479512":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":79,"locations":88,"responsibleParty":238,"collaborators":19,"id":240,"slug":241,"hasResults":242,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":19,"eligibilityCriteria":246,"healthyVolunteers":242,"sex":247,"minAge":248,"maxAge":19,"enrollmentInfo":249,"targetDuration":19,"studyType":252,"phases":253,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":91,"whyStopped":19,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"Yuhan Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"YH32367","EXPERIMENTAL","Dose Escalation Part: 8 Cohorts. In Dose Escalation part, patients are assigned to receive YH32367 at a starting dose and the dose being escalated\u002Fde-escalated in adjacent dose cohorts.\n\nDose Expansion Part: 2 Cohorts (Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). Dose Expansion part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and\u002For cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2).",[13],"Drug: YH32367",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Dose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated\u002Fde-escalated in adjacent dose cohorts will be up to Dose level 8.\n\nDose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and\u002For cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2). Each cohort will enroll approximately 75 and 40 patients, respectively.",[9],null,[21,25,28,31,34,37,40,43,46,49,52,55,58,61,64,67,70,73,76],{"name":22,"affiliation":23,"role":24},"Hyejin Choi","Severance Hospital","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Kyu-pyo Kim","Asan Medical Center",{"name":29,"affiliation":30,"role":24},"Do-Youn Oh","Seoul National University Hospital",{"name":32,"affiliation":33,"role":24},"Joon Oh Park","Samsung Medical Center",{"name":35,"affiliation":36,"role":24},"Ganessan Kichenadasse","Southern Oncology Clinical Research Unit",{"name":38,"affiliation":39,"role":24},"Jennifer Man","Blacktown Hospital",{"name":41,"affiliation":42,"role":24},"Arlene Chan","Breast Cancer Research Centre WA",{"name":44,"affiliation":45,"role":24},"Ju Won Kim","Korea University Anam Hospital",{"name":47,"affiliation":48,"role":24},"Myung Ah Lee","The Catholic University of Korea, St. Mary's hospital",{"name":50,"affiliation":51,"role":24},"Hongjae Chon","CHA Bundang Medical Center",{"name":53,"affiliation":54,"role":24},"Niall Tebbutt","Austin Health",{"name":56,"affiliation":57,"role":24},"Jung Hun Kang","Gyeongsang National University Hospital",{"name":59,"affiliation":60,"role":24},"Seok Yun Kang","Ajou University School of Medicine",{"name":62,"affiliation":63,"role":24},"Hyung Soon Park","Catholic University of Korea St. Vincent's Hospital",{"name":65,"affiliation":66,"role":24},"Ji Hong Bae","Gachon Gil University Medical Center",{"name":68,"affiliation":69,"role":24},"Cheol Kyung Sin","Ulsan University Hospital",{"name":71,"affiliation":72,"role":24},"Hae Seong Park","Dana-Farber Cancer Institute",{"name":74,"affiliation":75,"role":24},"Thatcher Heumman","Vanderbilt-Ingram Cancer Center",{"name":77,"affiliation":78,"role":24},"Hongsik Kim","Chungbuk National University Hospital",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":19,"email":84},"Clinical Operation Team 1","CONTACT","+82-2-828-0065","clinicaltrials@yuhan.co.kr",{"name":86,"role":82,"phone":83,"phoneExt":19,"email":87},"Heayeon Yoo","hy1221@yuhan.co.kr",[89,103,113,123,130,139,146,156,164,170,179,188,196,204,209,215,220,225,230],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":19},"Dana Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-71.05977,42.35843,{"lat":101,"lon":100},{"facility":104,"status":91,"city":105,"state":106,"zip":107,"country":95,"countryCode":96,"cosmosGeoPoint":108,"geoPoint":112,"contacts":19},"Vanderbilt Ingram Cancer Center","Nashville","Tennessee","37232",{"type":98,"coordinates":109},[110,111],-86.78444,36.16589,{"lat":111,"lon":110},{"facility":36,"status":114,"city":115,"state":19,"zip":19,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":19},"TERMINATED","Adelaide","Australia","AU",{"type":98,"coordinates":119},[120,121],138.59863,-34.92866,{"lat":121,"lon":120},{"facility":54,"status":91,"city":124,"state":19,"zip":19,"country":116,"countryCode":117,"cosmosGeoPoint":125,"geoPoint":129,"contacts":19},"Melbourne",{"type":98,"coordinates":126},[127,128],144.96332,-37.814,{"lat":128,"lon":127},{"facility":131,"status":132,"city":133,"state":19,"zip":19,"country":116,"countryCode":117,"cosmosGeoPoint":134,"geoPoint":138,"contacts":19},"Breast Cancer Research Centre - WA","WITHDRAWN","Perth",{"type":98,"coordinates":135},[136,137],115.8614,-31.95224,{"lat":137,"lon":136},{"facility":39,"status":91,"city":140,"state":19,"zip":19,"country":116,"countryCode":117,"cosmosGeoPoint":141,"geoPoint":145,"contacts":19},"Sydney",{"type":98,"coordinates":142},[143,144],151.20732,-33.86785,{"lat":144,"lon":143},{"facility":51,"status":91,"city":147,"state":148,"zip":149,"country":150,"countryCode":19,"cosmosGeoPoint":151,"geoPoint":155,"contacts":19},"Seongnam-si","Gyeonggi-do","13496","South Korea",{"type":98,"coordinates":152},[153,154],127.13778,37.43861,{"lat":154,"lon":153},{"facility":63,"status":91,"city":157,"state":148,"zip":158,"country":150,"countryCode":19,"cosmosGeoPoint":159,"geoPoint":163,"contacts":19},"Suwon","16247",{"type":98,"coordinates":160},[161,162],127.00889,37.29111,{"lat":162,"lon":161},{"facility":165,"status":91,"city":157,"state":148,"zip":166,"country":150,"countryCode":19,"cosmosGeoPoint":167,"geoPoint":169,"contacts":19},"Ajou University Hospital","16499",{"type":98,"coordinates":168},[161,162],{"lat":162,"lon":161},{"facility":57,"status":91,"city":171,"state":172,"zip":173,"country":150,"countryCode":19,"cosmosGeoPoint":174,"geoPoint":178,"contacts":19},"Jinju","Gyeongsangnam-do","52727",{"type":98,"coordinates":175},[176,177],128.08472,35.19278,{"lat":177,"lon":176},{"facility":78,"status":91,"city":180,"state":181,"zip":182,"country":150,"countryCode":19,"cosmosGeoPoint":183,"geoPoint":187,"contacts":19},"Cheongju-si","North Chungcheong","28644",{"type":98,"coordinates":184},[185,186],127.48972,36.63722,{"lat":186,"lon":185},{"facility":66,"status":91,"city":189,"state":19,"zip":190,"country":150,"countryCode":19,"cosmosGeoPoint":191,"geoPoint":195,"contacts":19},"Incheon","21565",{"type":98,"coordinates":192},[193,194],126.70515,37.45646,{"lat":194,"lon":193},{"facility":45,"status":91,"city":197,"state":19,"zip":198,"country":150,"countryCode":19,"cosmosGeoPoint":199,"geoPoint":203,"contacts":19},"Seoul","02841",{"type":98,"coordinates":200},[201,202],126.9784,37.566,{"lat":202,"lon":201},{"facility":30,"status":91,"city":197,"state":19,"zip":205,"country":150,"countryCode":19,"cosmosGeoPoint":206,"geoPoint":208,"contacts":19},"03080",{"type":98,"coordinates":207},[201,202],{"lat":202,"lon":201},{"facility":210,"status":91,"city":197,"state":19,"zip":211,"country":150,"countryCode":19,"cosmosGeoPoint":212,"geoPoint":214,"contacts":19},"Severance Hospital, Yonsei University Health System","03722",{"type":98,"coordinates":213},[201,202],{"lat":202,"lon":201},{"facility":27,"status":91,"city":197,"state":19,"zip":216,"country":150,"countryCode":19,"cosmosGeoPoint":217,"geoPoint":219,"contacts":19},"05505",{"type":98,"coordinates":218},[201,202],{"lat":202,"lon":201},{"facility":33,"status":91,"city":197,"state":19,"zip":221,"country":150,"countryCode":19,"cosmosGeoPoint":222,"geoPoint":224,"contacts":19},"06351",{"type":98,"coordinates":223},[201,202],{"lat":202,"lon":201},{"facility":48,"status":91,"city":197,"state":19,"zip":226,"country":150,"countryCode":19,"cosmosGeoPoint":227,"geoPoint":229,"contacts":19},"06591",{"type":98,"coordinates":228},[201,202],{"lat":202,"lon":201},{"facility":69,"status":91,"city":231,"state":19,"zip":232,"country":150,"countryCode":19,"cosmosGeoPoint":233,"geoPoint":237,"contacts":19},"Ulsan","44437",{"type":98,"coordinates":234},[235,236],129.31667,35.53722,{"lat":236,"lon":235},{"type":239,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100479512","phase-1-clinical-trial-of-yh32367-in-patients-with-her2-positive-locally-advanced-or-metastatic-solid-tumor-100479512",false,"NCT05523947","Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor","A Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n\\[Dose Escalation Part\\]\n\n* Pathologically confirmed HER2-positive\n* Mandatory provision of tumor tissue sample\n\n\\[Dose Expansion Part\\]\n\n* Patients who have at least one measurable lesion\n* Mandatory provision of tumor tissue sample\n\n  1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer\n  2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer\n\nExclusion Criteria:\n\n* Uncontrolled central nervous system (CNS) metastases\n* Spinal cord compression\n* Carcinomatous meningitis\n* Acute coronary syndromes\n* Heart failure\n* Interstitial lung disease (ILD)\n* Pneumonitis\n* History of a second primary cancer\n* Human immunodeficiency virus (HIV)\n* Active chronic hepatitis B\n* Hepatitis C\n* Systemic steroid therapy\n* Autoimmune disease","ALL","18 Years",{"count":250,"type":251},147,"ESTIMATED","INTERVENTIONAL",[254,255],"PHASE1","PHASE2","This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.",[258],"HER2-Positive Solid Tumor",[9,260,261,262,263,264,265],"HER2\u002F4-1BB bispecific antibody","Solid tumor","Breast cancer","Gastric cancer","HER2-positive","Biliary tract cancer","2026-06-09",{"date":268,"type":269},"2026-06-11","ACTUAL",{"date":271,"type":269},"2022-08-26",{"date":273,"type":251},"2028-04-30",{"name":5,"class":6},19]