[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617138":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":22,"studyPopulation":22,"armGroups":48,"interventions":61,"overallOfficials":22,"centralContacts":71,"locations":77,"responsibleParty":94,"collaborators":22,"id":96,"slug":22,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":22,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":22,"enrollmentInfo":104,"targetDuration":22,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":22,"overallStatus":80,"whyStopped":22,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"pCR (Arm 1 and 2)","Pathological complete response","Up to 24 months",{"measure":14,"description":15,"timeFrame":12},"cCR (Arm 3)","Clinical complete response",[17,20,23,26,28,31,34,37,40],{"measure":18,"description":19,"timeFrame":12},"cORR","Clinical objective response rate",{"measure":21,"description":22,"timeFrame":12},"Pathological downstaging rate (Arm 1 and 2)",null,{"measure":24,"description":25,"timeFrame":12},"DFS (Arm 1 and 2)","Disease-free survival",{"measure":27,"description":22,"timeFrame":12},"Duration of clinical complete response (Arm 3)",{"measure":29,"description":30,"timeFrame":12},"PFS (Arm 3)","Progression-free survival",{"measure":32,"description":33,"timeFrame":12},"OS","Overall Survival",{"measure":35,"description":36,"timeFrame":12},"AE\u002FSAE","Adverse event, serious adverse event",{"measure":38,"description":39,"timeFrame":12},"Immunogenicity","Anti-Drug Antibody (ADA) of 9MW2821",{"measure":41,"description":22,"timeFrame":12},"Nectin-4 and PD-L1 expression",{"allocation":43,"interventionModel":44,"interventionModelDescription":22,"primaryPurpose":45,"observationalModel":22,"timePerspective":22,"maskingInfo":46},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":22,"whoMasked":22},"NONE",[49,55,58],{"label":50,"type":51,"description":22,"interventionNames":52},"Arm 1: MIBC","EXPERIMENTAL",[53,54],"Drug: 9MW2821","Drug: Toripalimab Injection",{"label":56,"type":51,"description":22,"interventionNames":57},"Arm 2: High-risk UTUC",[53,54],{"label":59,"type":51,"description":22,"interventionNames":60},"Arm 3: MIBC",[53,54],[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":22},"DRUG","9MW2821","9MW2821, 1.25mg\u002Fkg, intravenous (IV) infusion",[50,56,59],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":22},"Toripalimab Injection","Toripalimab, 240mg, intravenous (IV) infusion",[50,56,59],[72],{"name":73,"role":74,"phone":75,"phoneExt":22,"email":76},"Zhuowei Liu, Professor","CONTACT","86-20-87343606","liuzhw@sysucc.org.cn",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":87,"coordinates":88},"Point",[89,90],113.25,23.11667,{"lat":90,"lon":89},[93],{"name":73,"role":74,"phone":75,"phoneExt":22,"email":76},{"type":95,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100617138",false,"NCT07314723","9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer","A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer","Inclusion Criteria:\n\n* Sign the informed consent form approved by IEC.\n* Male or female subjects aged ≥18 years old.\n* ECOG status: 0 or 1.\n* Histologically confirmed urothelial cancer.\n* Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.\n* Adequate tumor tissues submitted for test.\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* Prior systemic anti-tumor therapy for urothelial cancer.\n* Previously treated with PD-1\u002FPD-L1 inhibitors or antibody-drug conjugates (ADCs).\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 1 year.\n* Major surgery treated within 28 days; Cystoscopy\u002Fureteroscopy biopsy or intravesical instillation therapy within 7 days.\n* Peripheral neuropathy Grade ≥ 2.\n* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.\n* Active HBV\u002FHCV\u002FHIV infection, etc.\n* Any other serious chronic or uncontrolled disease.\n* Any live vaccines got within 28 days.\n* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* Any potent CYP3A4 inducers\u002Finhibitors taken within 14 days.\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",{"count":105,"type":106},90,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.",[112],"Urothelial Carcinoma","2025-12-18",{"date":115,"type":116},"2026-01-02","ACTUAL",{"date":118,"type":116},"2025-08-01",{"date":120,"type":106},"2028-12-31",{"name":5,"class":6},1]