[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522168":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":38,"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],{"label":9,"type":10,"description":11,"interventionNames":12},"9MW2821+Toripalimab","EXPERIMENTAL",null,[13,14],"Drug: 9MW2821","Drug: Toripalimab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","9MW2821","1.0\u002F1.25\u002F1.5 mg\u002Fkg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.",[9],[22],"9MW2821 injection",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Toripalimab","240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.",[9],[28],"Toripalimab injection",[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Jun Guo, Professor","CONTACT","010-88196358","guoj307@126.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100522168","phase-1-9mw2821-combined-with-toripalimab-injection-in-subjects-with-local-advanced-or-metastatic-urothelial-cancer-100522168",false,"NCT06079112","9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","A Phase Ib\u002FII, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","Inclusion Criteria:\n\n* Sign and date the informed consent form e approved by independent ethics committe.\n* Male or female subjects aged 18 to 80 years (including 18 and 80 years).\n* ECOG status of 0 or 1.\n* Histologically or cytologically confirmed local advanced or metastatic urothelial cancer\n* Subjects have received at least 1 line advanced standard therapy or were not treated before\n* Subjects must submit tumor tissues for test\n* Life expectancy of ≥ 12 weeks.\n* Subjects must have measurable lesions according to RECIST (version 1.1).\n* Adequate organ functions\n* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n* Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.\n* Major surgery within 28 days prior to first dose of study drug.\n* PD-1\u002FPD-L1\u002FPD-L2 inhibitors used in the previous treatment for La\u002Fm UC.\n* Previous treatment with ADCs conjugated with MMAE payload.\n* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.\n* Peripheral neuropathy Grade ≥ 2.\n* Poorly controlled blood sugar.\n* Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.\n* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n* Active infections, such as uncontrolled HBV\u002FHCV\u002FHIV\u002FTB infection, etc.\n* Other serious or uncontrolled diseases, such as serious interstitial pneumonia\u002Fasthma, serious thromboembolic events, etc.\n* Poorly controlled central nervous system metastases.\n* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* History of drug abuse or mental illness.\n* Known allergic sensitivity to any of the ingredients of the study drug.\n* Any P-glycoprotein (P-gp) inducers\u002Finhibitors or potent CYP3A4 inducers\u002Finhibitors within 14 days prior to the first dose of study drug.\n* History of autoimmune disease requiring systemic treatment within 2 years before the first dose.\n* Any live vaccines within 4 weeks before first dose of study drug or during the study.\n* Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.\n* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.\n* Other conditions unsuitable into the study.","ALL","18 Years","80 Years",{"count":65,"type":66},100,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","This is a phase Ib\u002FII, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.",[73],"Advanced Urothelial Carcinoma","2024-09-09",{"date":76,"type":77},"2024-09-19","ACTUAL",{"date":79,"type":77},"2023-09-27",{"date":81,"type":66},"2027-12-31",{"name":5,"class":6},1]