[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643574":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fudan University Shanghai Cancer Center","Shanghai","China","CN",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":25,"email":52},"Dingwei Ye","021-64175590","dwyeli@163.com",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100643574","phase-2-a-phase-ii-study-of-ak146d1-mono-or-combined-with-ak112-in-advanced-urothelial-carcinoma-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":66,"type":67},132,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73],"Urothelial Carcinoma (UC)","NOT_YET_RECRUITING","2026-06-04",{"date":77,"type":78},"2026-06-09","ACTUAL",{"date":80,"type":67},"2026-06-22",{"date":82,"type":67},"2028-08-24",{"name":5,"class":6},1]