[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroenteropancreatic-neuroendocrine-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroenteropancreatic-neuroendocrine-carcinoma":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":19,"type":20},116,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Small Cell Lung Carcinoma","Large Cell Neuroendocrine Carcinoma of the Lung","Neuroendocrine Prostate Cancer","Gastroenteropancreatic Neuroendocrine Carcinoma",[31,32,33,34,35,36,37,38,39],"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":43,"type":44},"2026-05-05","ACTUAL",{"date":46,"type":44},"2025-10-16",{"date":48,"type":20},"2031-08-29",{"name":50,"class":51},"Novartis Pharmaceuticals","INDUSTRY",6,""]