[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561604":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":57,"overallOfficials":36,"centralContacts":81,"locations":87,"responsibleParty":104,"collaborators":36,"id":106,"slug":36,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":36,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":36,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":36,"overallStatus":90,"whyStopped":36,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"BICR-PFS","Progression-free survival, assessed by BICR","up to 50 months",{"measure":14,"description":15,"timeFrame":12},"OS","Overall Survival",[17,21,24,27,30,33],{"measure":18,"description":19,"timeFrame":20},"ORR","Objective response rate, assessed by BICR or investigator","Up to 50 months",{"measure":22,"description":23,"timeFrame":20},"DCR","Disease control rate, assessed by BICR or investigator",{"measure":25,"description":26,"timeFrame":20},"DoR","Duration of response, assessed by BICR or investigator",{"measure":28,"description":29,"timeFrame":20},"PFS","Progression-free survival, assessed by investigator",{"measure":31,"description":32,"timeFrame":20},"AE\u002FSAE","Adverse event, serious adverse event",{"measure":34,"description":35,"timeFrame":20},"Immunogenicity","Anti-Drug Antibody (ADA) of 9MW2821",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.",[45,51],{"label":46,"type":47,"description":46,"interventionNames":48},"9MW2821+Toripalimab","EXPERIMENTAL",[49,50],"Drug: 9MW2821","Drug: Toripalimab",{"label":52,"type":53,"description":52,"interventionNames":54},"Gemcitabine+Cisplatin\u002FCarboplatin","ACTIVE_COMPARATOR",[55,56],"Drug: Gemcitabine","Drug: Cisplatin\u002FCarboplatin",[58,63,69,75],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":36},"DRUG","9MW2821","9MW2821, 1.25mg\u002Fkg, intravenous (IV) infusion",[46],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Toripalimab","Toripalimab, 240mg, intravenous (IV) infusion",[46],[68],"Toripalimab injection",{"type":59,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Gemcitabine","Gemcitabine: 1000mg\u002Fm2, intravenous (IV) infusion",[52],[74],"Gemcitabine Hydrochloride for Injection",{"type":59,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Cisplatin\u002FCarboplatin","Cisplatin: 70mg\u002Fm2 or Carboplatin: AUC=4.5\u002F5, intravenous (IV) infusion.",[52],[80],"Cisplatin for injection\u002FCarboplatin Injection",[82],{"name":83,"role":84,"phone":85,"phoneExt":36,"email":86},"Dingwei Ye, Professor","CONTACT","13701663571","fuscc2012@163.com",[88],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":97,"coordinates":98},"Point",[99,100],121.45806,31.22222,{"lat":100,"lon":99},[103],{"name":83,"role":84,"phone":85,"phoneExt":36,"email":86},{"type":105,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":116,"type":117},460,"ESTIMATED","INTERVENTIONAL",[120],"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.",[123],"Urothelial Carcinoma","2024-09-09",{"date":126,"type":127},"2024-09-19","ACTUAL",{"date":129,"type":127},"2024-08-22",{"date":131,"type":117},"2028-12",{"name":5,"class":6},1]