[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-expressing\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-expressing":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},452,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Urothelial Carcinoma","HER2-expressing",[26,27,29,30],"RC48","First-Line","RECRUITING","2023-12-15",{"date":34,"type":35},"2023-12-18","ACTUAL",{"date":37,"type":35},"2022-06-14",{"date":39,"type":20},"2028-04-30",{"name":41,"class":42},"RemeGen Co., Ltd.","INDUSTRY",2]