[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595872":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":29,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":29,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":29,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":29,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase Ib: Part1-Dose Escalation","EXPERIMENTAL","This study will employ the traditional \"3+3\" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.",[13,14],"Drug: ZG006","Drug: ZG005",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase Ib: Part2-Dose Expansion","The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Phase II","Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","ZG006","ZG006 will be administered as an intravenous (IV) infusion.",[20,9,16],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"ZG005","ZG005 will be administered as an intravenous (IV) infusion.",[20,9,16],[35],{"name":36,"affiliation":5,"role":37},"Jason Wu","STUDY_CHAIR",[39],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Hewen Yin","CONTACT","+86-0512-57309965","yinhw@zelgen.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":29,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Sun Yat-sen University Cancer Center","RECRUITING","Guanzhou","Guangdong","China","CN",{"type":53,"coordinates":54},"Point",[55,56],113.37117,23.06828,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":29,"phoneExt":29,"email":29},"Li Zhang",{"type":62,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100595872","phase-1-zg006-and-zg005-in-participants-with-small-cell-lung-cancer-or-neuroendocrine-carcinoma-100595872",false,"NCT07038096","ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","A Phase Ib\u002FII Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)","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* Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.\n* Eastern Cooperative Oncology Group (ECOG) 0 to 1.\n* Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n* The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.","ALL","18 Years","70 Years",{"count":74,"type":75},350,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","This study is a randomized, multicenter, Phase Ib\u002FII clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.",[82,83],"Small Cell Lung Cancer","Neuroendocrine Carcinoma","2025-12-30",{"date":86,"type":87},"2026-01-05","ACTUAL",{"date":89,"type":87},"2025-09-23",{"date":91,"type":75},"2027-09",{"name":5,"class":6},1]