[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544725":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":27,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":27,"overallStatus":53,"whyStopped":27,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Escalation","EXPERIMENTAL","Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.",[13,14,15],"Biological: ZG005","Drug: Etoposide","Drug: Cisplatin",{"label":17,"type":10,"description":18,"interventionNames":19},"Part 2: Dose Expansion","Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.",[13,14,15,20],"Drug: Placebo",[22,28,33,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","ZG005","ZG005 for dose escalations are set as 10mg\u002Fkg, 20mg\u002Fkg, and the other doses after discussion. intravenous infusion, once every 3 weeks.\n\nZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.",[9,17],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","Etoposide","IV infusion",[9,17],{"type":29,"name":34,"description":31,"armGroupLabels":35,"otherNames":27},"Cisplatin",[9,17],{"type":29,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Placebo","0.9% Sodium Chloride Injection",[17],[41],{"name":42,"affiliation":5,"role":43},"Jason Wu","STUDY_CHAIR",[45],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Cheng Wei","CONTACT","+8651257309965","weic@zelgen.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":60,"coordinates":61},"Point",[62,63],116.39723,39.9075,{"lat":63,"lon":62},[66],{"name":67,"role":47,"phone":27,"phoneExt":27,"email":27},"Jianming Xu",{"type":69,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100544725","phase-1-study-of-zg005-in-combination-with-etoposide-and-cisplatin-in-participants-with-advanced-neuroendocrine-carcinoma-100544725",false,"NCT06372626","Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.","A Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Histologically confirmed recurrent or metastatic neuroendocrine carcinoma\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;\n* Any other malignancy within 5 years.\n* participants were deemed unsuitable for participating in the study by the investigator for any reasons.","ALL","18 Years","70 Years",{"count":81,"type":82},93,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.",[89],"Neuroendocrine Carcinoma","2024-06-13",{"date":92,"type":93},"2024-06-14","ACTUAL",{"date":95,"type":93},"2024-05-30",{"date":97,"type":82},"2026-08",{"name":5,"class":6},1]