[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-prostate-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100593460","phase-1-phase-i-study-of-225acac-etn029-in-patients-with-advanced-dll3-expressing-solid-tumors-100593460",false,"NCT07006727","Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors","A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n* Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Prior DLL3-targeted therapy is allowed. For dose expansion, patients should have received no more than 2 prior lines of systemic therapy.\n* Dose escalation only: LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy.\n* Dose expansion only: Locally advanced, unresectable, or metastatic de novo or castration-resistant, treatment-emergent NEPC with neuroendocrine differentiation confirmed by local histology and NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC. Prior PSMA-targeted, Lu-177-based RLT is allowed. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT\u002FCT as assessed by the Investigator.\n* Dose expansion only: Locally advanced, unresectable, or metastatic GEP-NEC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT\u002FCT as assessed by the Investigator.\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.0 x 109\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 75 x 109\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* eGFR \\\u003C 60 mL\u002Fmin (\\\u003C0.835 mL\u002Fs), calculated using the CKD-EPI 2021 formula or measured\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Presence of leptomeningeal disease, of symptomatic CNS metastases or of CNS metastases that require local CNS-directed therapy\n* History of or current interstitial lung disease or pneumonitis ≥ Grade 2\n* Any prior DLL3-targeted therapy (except for SCLC) and any prior RLT (except for NEPC)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[225Ac\\]Ac-ETN029 and the safety and imaging properties of \\[111In\\]In-ETN029 in patients aged ≥ 18 years with locally advanced or metastatic DLL3 positive cancers.",[27,28,29,30],"Small Cell Lung Carcinoma","Large Cell Neuroendocrine Carcinoma of the Lung","Neuroendocrine Prostate Cancer","Gastroenteropancreatic Neuroendocrine Carcinoma",[32,33,34,35,36,37,38,39,40],"Small Cell Lung Carcinoma (SCLC)","Large Cell Neuroendocrine Carcinoma of the Lung (LCNEC)","Neuroendocrine Prostate Cancer (NEPC)","Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)","DLL3","Neuroendocrine neoplasms","Radioligand therapy (RLT)","[225Ac]Ac-ETN029","[111In]In-ETN029","RECRUITING","2026-05-04",{"date":44,"type":45},"2026-05-05","ACTUAL",{"date":47,"type":45},"2025-10-16",{"date":49,"type":21},"2031-08-29",{"name":51,"class":52},"Novartis Pharmaceuticals","INDUSTRY",6,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":61,"minAge":17,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100594809","phase-2-study-of-zg006-in-participants-with-neuroendocrine-prostate-cancer-100594809","NCT07024277","Study of ZG006 in Participants With Neuroendocrine Prostate Cancer","A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer","Inclusion Criteria:\n\n* Male Participants aged 18 to 80 years (inclusive);\n* Advanced metastatic neuroendocrine prostate cancer;\n* disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity;\n* Measurable disease according to RECIST v1.1 criteria;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Known positive test for human immunodeficiency virus (HIV) or hepatitis；\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.","MALE","80 Years",{"count":64,"type":21},60,[66],"PHASE2","This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.",[29],"NOT_YET_RECRUITING","2025-06-09",{"date":72,"type":45},"2025-06-17",{"date":74,"type":21},"2025-08",{"date":76,"type":21},"2027-12",{"name":78,"class":52},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",1]