[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548720":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":69,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FZ-AD005","EXPERIMENTAL",null,[13],"Drug: FZ-AD005",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Mengli Zhou","CONTACT","00-86-021-58953355","mlzhou@fd-zj.com",[26,43,56],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Hunan Cancer Hospital","RECRUITING","Changsha","Hunan","410013","China","CN",{"type":35,"coordinates":36},"Point",[37,38],112.97087,28.19874,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":11,"phoneExt":11,"email":11},"Lin Wu",{"facility":44,"status":28,"city":45,"state":46,"zip":47,"country":32,"countryCode":33,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Shanghai East Hospital","Shanghai","Shanghai Municipality","200120",{"type":35,"coordinates":49},[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":55,"role":22,"phone":11,"phoneExt":11,"email":11},"Caicun Zhou",{"facility":57,"status":28,"city":58,"state":59,"zip":60,"country":32,"countryCode":33,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang","310022",{"type":35,"coordinates":62},[63,64],120.16142,30.29365,{"lat":64,"lon":63},[67],{"name":68,"role":22,"phone":11,"phoneExt":11,"email":11},"Zhengbo Song",{"type":70,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100548720","phase-1-a-study-of-fz-ad005-in-patients-with-advanced-solid-tumors-100548720",false,"NCT06424665","A Study of FZ-AD005 in Patients With Advanced Solid Tumors","A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients able to give written informed consent;\n2. Age ≥ 18 and ≤ 75 years old, male or female;\n3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);\n4. Willingness to provide tumor tissue for testing ;\n5. Have measurable lesions defined in RECIST v. 1.1;\n6. Expected survival ≥ 3 months;\n7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;\n8. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.\n\nExclusion Criteria:\n\n1. Patients who have had previous treatment with any anti-DLL3 antibody；\n2. Have had other malignant tumors in the past 5 years;\n3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;\n4. Have active CNS (central nervous system) metastasis；\n5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;\n6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;\n7. Patients have psychiatric history;\n8. Female patients who are breastfeeding or pregnant;\n9. Other reasons that researchers believe are inappropriate to participate in this study.","ALL","18 Years","75 Years",{"count":82,"type":83},162,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.",[89],"Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)","2026-03-02",{"date":92,"type":93},"2026-03-04","ACTUAL",{"date":95,"type":93},"2024-07-03",{"date":97,"type":83},"2027-12-01",{"name":5,"class":6},3]