[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617138":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",[8,15,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: MIBC","EXPERIMENTAL",null,[13,14],"Drug: 9MW2821","Drug: Toripalimab Injection",{"label":16,"type":10,"description":11,"interventionNames":17},"Arm 2: High-risk UTUC",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"Arm 3: MIBC",[13,14],[22,27],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","9MW2821","9MW2821, 1.25mg\u002Fkg, intravenous (IV) infusion",[9,16,19],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Toripalimab Injection","Toripalimab, 240mg, intravenous (IV) infusion",[9,16,19],[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Zhuowei Liu, Professor","CONTACT","86-20-87343606","liuzhw@sysucc.org.cn",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":47,"coordinates":48},"Point",[49,50],113.25,23.11667,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100617138","phase-2-9mw2821-combined-with-toripalimab-in-perioperative-patients-with-urothelial-cancer-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":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73],"Urothelial Carcinoma","2025-12-18",{"date":76,"type":77},"2026-01-02","ACTUAL",{"date":79,"type":77},"2025-08-01",{"date":81,"type":67},"2028-12-31",{"name":5,"class":6},1]