[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594809":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":24,"overallStatus":73,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part2","EXPERIMENTAL","Participants will receive the RP2D identified in Part 1 of the study.",[13],"Biological: ZG006",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1","The preliminary efficacy and safety of ZG006 at the two determined potential Phase II recommended doses (10 mg and 30 mg) will be assessed in Participants with advanced metastatic NEPC.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","ZG006","ZG006 will be administered as an intravenous (IV) infusion.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Jason Wu","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Shangdi Ning","CONTACT","+86-0512-57309965","ningsd@zelgen.com",[36],{"facility":37,"status":24,"city":38,"state":39,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fudan university shanghai cancer center","Shanghai","Shanghai Municipality","China","CN",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":24,"phoneExt":24,"email":51},"Dingwei Ye","dwyeli@163.com",{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100594809","phase-2-study-of-zg006-in-participants-with-neuroendocrine-prostate-cancer-100594809",false,"NCT07024277","Study of ZG006 in Participants With Neuroendocrine Prostate Cancer","A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer","Inclusion Criteria:\n\n* Male Participants aged 18 to 80 years (inclusive);\n* Advanced metastatic neuroendocrine prostate cancer;\n* disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity;\n* Measurable disease according to RECIST v1.1 criteria;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Known positive test for human immunodeficiency virus (HIV) or hepatitis；\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.","MALE","18 Years","80 Years",{"count":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.",[72],"Neuroendocrine Prostate Cancer","NOT_YET_RECRUITING","2025-06-09",{"date":76,"type":77},"2025-06-17","ACTUAL",{"date":79,"type":66},"2025-08",{"date":81,"type":66},"2027-12",{"name":5,"class":6},1]