[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577852":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":178,"collaborators":25,"id":180,"slug":25,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":25,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":25,"enrollmentInfo":188,"targetDuration":25,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a: Dose Escalation and Safety Expansion","EXPERIMENTAL","Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.",[13],"Drug: BGB-B455",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1b: Dose Expansion","Recommended Dose(s) for Expansion (RDFE\\[s\\]) of BGB-B455 determined from Phase 1a as monotherapy or in combination with investigator-selected chemotherapy will be evaluated for selected indications based on emerging data.",[13,18],"Drug: Chemotherapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","BGB-B455","Planned doses administered on specified days per protocol.",[9,15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Chemotherapy","Administered in accordance with relevant local guidelines and\u002For prescribing information.",[15],[31],{"name":32,"affiliation":5,"role":33},"Study Director","STUDY_DIRECTOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","1.877.828.5568","clinicaltrials@beonemed.com",[40,54,64,74,84,94,106,115,125,138,148,158,168],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Adventhealth","RECRUITING","Celebration","Florida","34747-4606","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-81.53313,28.32529,{"lat":52,"lon":51},{"facility":55,"status":42,"city":56,"state":57,"zip":58,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":25},"Sidney Kimmel Cancer Center","Philadelphia","Pennsylvania","19107-4307",{"type":49,"coordinates":60},[61,62],-75.16362,39.95238,{"lat":62,"lon":61},{"facility":65,"status":42,"city":66,"state":67,"zip":68,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":25},"Avera Cancer Institute","Sioux Falls","South Dakota","57105-2108",{"type":49,"coordinates":70},[71,72],-96.72796,43.54369,{"lat":72,"lon":71},{"facility":75,"status":42,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":25},"Next Oncology","San Antonio","Texas","78229-6028",{"type":49,"coordinates":80},[81,82],-98.49363,29.42412,{"lat":82,"lon":81},{"facility":85,"status":42,"city":86,"state":87,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109-4433",{"type":49,"coordinates":90},[91,92],-122.33207,47.60621,{"lat":92,"lon":91},{"facility":95,"status":42,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":25},"Blacktown Cancer and Haematology Centre","Blacktown","New South Wales","NSW 2148","Australia","AU",{"type":49,"coordinates":102},[103,104],150.91667,-33.76667,{"lat":104,"lon":103},{"facility":107,"status":42,"city":108,"state":97,"zip":109,"country":99,"countryCode":100,"cosmosGeoPoint":110,"geoPoint":114,"contacts":25},"Liverpool Hospital","Liverpool","NSW 2170",{"type":49,"coordinates":111},[112,113],150.92588,-33.91938,{"lat":113,"lon":112},{"facility":116,"status":42,"city":117,"state":118,"zip":119,"country":99,"countryCode":100,"cosmosGeoPoint":120,"geoPoint":124,"contacts":25},"Mater Cancer Care Centre","South Brisbane","Queensland","QLD 4101",{"type":49,"coordinates":121},[122,123],153.02049,-27.48034,{"lat":123,"lon":122},{"facility":126,"status":127,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":25},"Beijing Cancer Hospital","COMPLETED","Beijing","Beijing Municipality","100142","China","CN",{"type":49,"coordinates":134},[135,136],116.39723,39.9075,{"lat":136,"lon":135},{"facility":139,"status":42,"city":140,"state":141,"zip":142,"country":131,"countryCode":132,"cosmosGeoPoint":143,"geoPoint":147,"contacts":25},"Sun Yat Sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":49,"coordinates":144},[145,146],113.25,23.11667,{"lat":146,"lon":145},{"facility":149,"status":42,"city":150,"state":151,"zip":152,"country":131,"countryCode":132,"cosmosGeoPoint":153,"geoPoint":157,"contacts":25},"The First Affiliated Hospital of Nanchang University Branch Donghu","Nanchang","Jiangxi","330006",{"type":49,"coordinates":154},[155,156],115.85306,28.68396,{"lat":156,"lon":155},{"facility":159,"status":42,"city":160,"state":161,"zip":162,"country":131,"countryCode":132,"cosmosGeoPoint":163,"geoPoint":167,"contacts":25},"Fudan University Shanghai Cancer Centerpudong","Shanghai","Shanghai Municipality","201321",{"type":49,"coordinates":164},[165,166],121.45806,31.22222,{"lat":166,"lon":165},{"facility":169,"status":42,"city":170,"state":171,"zip":172,"country":131,"countryCode":132,"cosmosGeoPoint":173,"geoPoint":177,"contacts":25},"Shanxi Provincial Cancer Hospital","Taiyuan","Shanxi","030013",{"type":49,"coordinates":174},[175,176],112.56028,37.86944,{"lat":176,"lon":175},{"type":179,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100577852",false,"NCT06803680","A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.\n* Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.\n* Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.\n* ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese \\[or other country\\] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).\n* Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).\n* Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n* Any major surgical procedure ≤ 28 days before the first dose of study drug(s).\n* History of prior ≥ Grade 3 cytokine release syndrome (CRS).\n* Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":189,"type":190},90,"ESTIMATED","INTERVENTIONAL",[193],"PHASE1","The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.\n\nThe main questions it aims to answer are:\n\n* What is the recommended dosing for BGB-B455?\n* What medical problems do participants have when taking BGB-B455?\n\nThe study has two parts:\n\n* Phase 1a: dose escalation and safety expansion\n* Phase 1b: dose expansion",[196,197],"Advanced Solid Tumor","Metastatic Solid Tumor",[199,200,201,202,203,204,205,206],"Claudin-6","CLDN6+","advanced or metastatic solid tumor","CD3","BsAb","bispecific antibody","CD3-BsAb","CLDN","2026-05-20",{"date":209,"type":210},"2026-05-22","ACTUAL",{"date":212,"type":210},"2025-03-18",{"date":214,"type":190},"2028-04-29",{"name":5,"class":6},13]