[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumor-sclcsmall-cell-lung-cancer-or-lcnec-large-cell-neuroendocrine-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumor-sclcsmall-cell-lung-cancer-or-lcnec-large-cell-neuroendocrine-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},162,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)","RECRUITING","2026-03-02",{"date":31,"type":32},"2026-03-04","ACTUAL",{"date":34,"type":32},"2024-07-03",{"date":36,"type":21},"2027-12-01",{"name":38,"class":39},"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","INDUSTRY",3]