[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534012":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":41,"responsibleParty":60,"collaborators":39,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":39,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":39,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":39,"overallStatus":44,"whyStopped":39,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Escalation","EXPERIMENTAL","The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).",[13],"Biological: ZG005 Powder for Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy","The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma",[13],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","ZG005 Powder for Injection","The dose groups of ZG005 for dose escalations are set as 0.3 mg\u002Fkg, 1mg\u002Fkg, 3mg\u002Fkg, 10mg\u002Fkg, and 20mg\u002Fkg, intravenous infusion, once every 3 weeks.",[9],[25],"ZG005",{"type":20,"name":21,"description":27,"armGroupLabels":28,"otherNames":29},"Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.",[15],[25],[31],{"name":32,"affiliation":5,"role":33},"Jason Wu","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Yongsheng Chu","CONTACT","+86-0512-57309965",null,"chuys@zelgen.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Zhejiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.16142,30.29365,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":39,"phoneExt":39,"email":59},"Hanmei Lou","louhm@zjcc.org.cn",{"type":61,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100534012","phase-1-a-study-of-zg005-in-patients-with-advanced-solid-tumors-100534012",false,"NCT06233292","A Study of ZG005 in Patients With Advanced Solid Tumors","A Phase 1\u002F2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors","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 0-2;\n* Life expectancy ≥ 3 months;\n* Histologically or cytologically confirmed diagnosis of advanced solid tumors.\n\nExclusion Criteria:\n\n* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;\n* Any other malignancy within 5 years.","ALL","18 Years","70 Years",{"count":73,"type":74},484,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE1","PHASE2","This is a multi-center, open-label, Phase 1\u002F2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD\u002Frecommended dose.",[81],"Solid Tumors","2024-06-13",{"date":84,"type":85},"2024-06-14","ACTUAL",{"date":87,"type":85},"2022-06-17",{"date":89,"type":74},"2026-01",{"name":5,"class":6},1]