[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561604":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":45,"locations":51,"responsibleParty":68,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":9,"interventionNames":11},"9MW2821+Toripalimab","EXPERIMENTAL",[12,13],"Drug: 9MW2821","Drug: Toripalimab",{"label":15,"type":16,"description":15,"interventionNames":17},"Gemcitabine+Cisplatin\u002FCarboplatin","ACTIVE_COMPARATOR",[18,19],"Drug: Gemcitabine","Drug: Cisplatin\u002FCarboplatin",[21,27,33,39],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","9MW2821","9MW2821, 1.25mg\u002Fkg, intravenous (IV) infusion",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Toripalimab","Toripalimab, 240mg, intravenous (IV) infusion",[9],[32],"Toripalimab injection",{"type":22,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Gemcitabine","Gemcitabine: 1000mg\u002Fm2, intravenous (IV) infusion",[15],[38],"Gemcitabine Hydrochloride for Injection",{"type":22,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Cisplatin\u002FCarboplatin","Cisplatin: 70mg\u002Fm2 or Carboplatin: AUC=4.5\u002F5, intravenous (IV) infusion.",[15],[44],"Cisplatin for injection\u002FCarboplatin Injection",[46],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Dingwei Ye, Professor","CONTACT","13701663571","fuscc2012@163.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":61,"coordinates":62},"Point",[63,64],121.45806,31.22222,{"lat":64,"lon":63},[67],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},{"type":69,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100561604","phase-3-9mw2821-in-combination-with-toripalimab-vs-standard-chemotherapy-in-locally-advanced-or-metastatic-urothelial-cancer-100561604",false,"NCT06592326","9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer","A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer","Inclusion Criteria:\n\n* Sign the informed consent form approved by IEC.\n* Male or female subjects aged 18 to 80 years.\n* ECOG status: 0 or 1.\n* Histologically confirmed local advanced or metastatic urothelial cancer\n* Previously untreated with local advanced or metastatic urothelial cancer\n* At least one measurable lesion, according to RECIST V1.1.\n* Adequate tumor tissues submitted for test\n* Suitable for cisplatin\u002Fcarboplatin-based chemotherapy assessed by investigator\n* Life expectancy for more than 12 weeks.\n* Adequate organ functions.\n* Proper contraception methods.\n* Willingness to follow the study procedures.\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years.\n* History of autoimmune disease requiring systemic treatment within 2 years.\n* History of clinically significant cardiac\u002Fcerebrovascular diseases or thrombosis within 6 months.\n* Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers\u002Finhibitors taken within 14 days.\n* Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.\n* Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.\n* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.\n* Peripheral neuropathy Grade ≥ 2.\n* Any other serious chronic or uncontrolled disease.\n* Uncontrolled central nervous system metastases or carcinomatous meningitis.\n* Active HBV\u002FHCV\u002FHIV infection, etc.\n* Known allergic sensitivity to any of the ingredients of the study drug.\n* History of drug abuse or mental illness.\n* Other conditions unsuitable into the study.","ALL","18 Years","80 Years",{"count":81,"type":82},460,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.",[88],"Urothelial Carcinoma","2024-09-09",{"date":91,"type":92},"2024-09-19","ACTUAL",{"date":94,"type":92},"2024-08-22",{"date":96,"type":82},"2028-12",{"name":5,"class":6},1]