[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462486":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":85,"collaborators":41,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":41,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":41,"enrollmentInfo":96,"targetDuration":41,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":63,"whyStopped":41,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"RemeGen Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"RC48-ADC + JS001","EXPERIMENTAL","Participants will receive RC48-ADC + JS001 every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).",[13,14],"Drug: RC48-ADC","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Gemcitabine + cisplatin\u002Fcarboplatin","ACTIVE_COMPARATOR","Participants will receive Gemcitabine + cisplatin or carboplatin every 3 weeks (Q3W) for maximum 6 weeks or until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).",[20,21,22],"Drug: Gemcitabine","Drug: Cisplatin","Drug: Carboplatin",[24,31,37,42,46],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","RC48-ADC","2.0 mg\u002Fkg IV every 2 weeks",[9],[30],"Disitamab Vedotin",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Toripalimab","3.0 mg\u002Fkg IV every 2 weeks",[9],[36],"JS001",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Gemcitabine","1000mg\u002Fm2 IV infusion on Days 1 and 8 of every 3 week cycle",[16],null,{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Cisplatin","70mg\u002Fm2 IV infusion on Day 1 of every 3 week cycle",[16],{"type":25,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Carboplatin","AUC=4.5, IV infusion on Day 1 of every 3 week cycle",[16],[51],{"name":52,"affiliation":5,"role":53},"Na Su, PhD","STUDY_DIRECTOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":41,"email":59},"Jianmin Fang, PhD","CONTACT","+86-010-58075561","jianminfang@hotmail.com",[61,77],{"facility":62,"status":63,"city":64,"state":65,"zip":41,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Cancer Hospital Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":69,"coordinates":70},"Point",[71,72],116.39723,39.9075,{"lat":72,"lon":71},[75],{"name":76,"role":57,"phone":41,"phoneExt":41,"email":41},"Aiping zhou",{"facility":78,"status":63,"city":64,"state":41,"zip":41,"country":66,"countryCode":67,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Beijing Cancer Hospital",{"type":69,"coordinates":80},[71,72],{"lat":72,"lon":71},[83],{"name":84,"role":57,"phone":41,"phoneExt":41,"email":41},"Jun Guo",{"type":86,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100462486","phase-3-a-study-of-rc48-adc-combined-with-toripalimab-for-first-line-treatment-of-urothelial-carcinoma-100462486",false,"NCT05302284","A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma","A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing","Inclusion Criteria:\n\n* Expected survival ≥12 weeks.\n* Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.\n* Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:\n\nParticipants that received neoadjuvant chemotherapy with recurrence \\>6 months from completion of therapy are permitted; Participants that received adjuvant chemotherapy following cystectomy with recurrence \\>6 months from completion of therapy are permitted.\n\n* At least one measurable lesion based on RECIST version 1.1\n* HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.\n* ECOG performance status score: 0 or 1.\n* Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.\n\nExclusion Criteria:\n\n* Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.\n* History of major surgery within 4 weeks of planned start of trial treatment.\n* Toxicity from a previous treatment has not returned to Grade 0-1.\n* Prior ADCs or PD-1\u002FPD-L1 inhibitor therapy.\n* Active central nervous system (CNS) metastases.\n* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.\n* History of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.\n* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.\n* Active autoimmune diseases that require systemic therapy over the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed.\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.","ALL","18 Years",{"count":97,"type":98},452,"ESTIMATED","INTERVENTIONAL",[101],"PHASE3","This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.",[104,105],"Urothelial Carcinoma","HER2-expressing",[104,105,107,108],"RC48","First-Line","2023-12-15",{"date":111,"type":112},"2023-12-18","ACTUAL",{"date":114,"type":112},"2022-06-14",{"date":116,"type":98},"2028-04-30",{"name":5,"class":6},2]