[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643574":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":25,"id":54,"slug":25,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","AK146D1 combined with AK112",[13,14],"Drug: AK146D1 for injection","Drug: AK112 Injection",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm B","AK146D1 mono",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AK146D1 for injection","AK146D1 for injection is an antiTrop2\u002FNectin4 bispecific antibody-drug conjugate",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"AK112 Injection","AK112 Injection is a PD-1\u002FVEGF bispecific antibody",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Ting Liu","CONTACT","+86 (0760) 8987 3999","clinicaltrials@akesobio.com",[37],{"facility":38,"status":25,"city":39,"state":25,"zip":25,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fudan University Shanghai Cancer Center","Shanghai","China",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":33,"phone":50,"phoneExt":25,"email":51},"Dingwei Ye","021-64175590","dwyeli@163.com",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100643574",false,"NCT07636772","A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma","A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n* Be able to understand and voluntarily sign the written informed consent form.\n* Age 18-75.\n* ECOG PS 0 or 1.\n* Expected lifespan ≥3 months.\n* Histologically or cytologically documented Urothelial carcinoma.\n* At least one measurable lesion according to RECIST v1.1.\n* Sufficient organ function.\n\nExclusion Criteria:\n\n* Having other active malignancies within 3 years.\n* Currently participating in another interventional clinical study.\n* Presence of active metastases to the central nervous system.\n* Prior chemotherapy agent targeting topoisomerase I .\n* Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.\n* Patients with active autoimmune diseases requiring systemic treatment within 2 years.\n* Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.\n* Previous history of severe hypersensitivity reactions.\n* Patients with a history of mental illness and incapacitated or limited capacity.\n* Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.","ALL","18 Years","75 Years",{"count":64,"type":65},132,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.",[71],"Urothelial Carcinoma (UC)","NOT_YET_RECRUITING","2026-06-04",{"date":75,"type":76},"2026-06-09","ACTUAL",{"date":78,"type":65},"2026-06-22",{"date":80,"type":65},"2028-08-24",{"name":5,"class":6},1]