[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593460":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":127,"collaborators":21,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":21,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":21,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":37,"whyStopped":21,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029",[13,14],"Drug: 225Ac-ETN029","Drug: 111In-ETN029",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","225Ac-ETN029","Radioligand therapy",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"111In-ETN029","Radioligand imaging agent",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":28,"role":29,"phone":33,"phoneExt":21,"email":31},"+41613241111",[35,57,73,90,106,118],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Of Iowa","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-91.53017,41.66113,{"lat":47,"lon":46},[50,54],{"name":51,"role":29,"phone":52,"phoneExt":21,"email":53},"Kellie Bodeker","319-356-2197","kellie-bodeker@uiowa.edu",{"name":55,"role":56,"phone":21,"phoneExt":21,"email":21},"Yusuf Menda","PRINCIPAL_INVESTIGATOR",{"facility":58,"status":37,"city":59,"state":60,"zip":61,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":44,"coordinates":63},[64,65],-71.05977,42.35843,{"lat":65,"lon":64},[68,71],{"name":69,"role":29,"phone":21,"phoneExt":21,"email":70},"Mingyuan Tommy Song","msong15@mgh.harvard.edu",{"name":72,"role":56,"phone":21,"phoneExt":21,"email":21},"Shadi Abdar Esfahani",{"facility":74,"status":37,"city":75,"state":76,"zip":77,"country":41,"countryCode":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Corewell Health William Beaum Hosp","Royal Oak","Michigan","48073-6769",{"type":44,"coordinates":79},[80,81],-83.14465,42.48948,{"lat":81,"lon":80},[84,88],{"name":85,"role":29,"phone":86,"phoneExt":21,"email":87},"Matthew Johnson","248-898-2697","matthew.johnson3@corewellhealth.org",{"name":89,"role":56,"phone":21,"phoneExt":21,"email":21},"Andrew Thompson",{"facility":91,"status":37,"city":92,"state":93,"zip":94,"country":41,"countryCode":42,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109-1024",{"type":44,"coordinates":96},[97,98],-122.33207,47.60621,{"lat":98,"lon":97},[101,104],{"name":102,"role":29,"phone":21,"phoneExt":21,"email":103},"Akshata Mathur","amathur2@fredhutch.org",{"name":105,"role":56,"phone":21,"phoneExt":21,"email":21},"Delphine Chen",{"facility":107,"status":37,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":21},"Novartis Investigative Site","Montreal","Quebec","H3T 1E2","Canada","CA",{"type":44,"coordinates":114},[115,116],-73.58781,45.50884,{"lat":116,"lon":115},{"facility":107,"status":37,"city":119,"state":21,"zip":120,"country":121,"countryCode":21,"cosmosGeoPoint":122,"geoPoint":126,"contacts":21},"Seoul","03080","South Korea",{"type":44,"coordinates":123},[124,125],126.9784,37.566,{"lat":125,"lon":124},{"type":128,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","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":140,"type":141},116,"ESTIMATED","INTERVENTIONAL",[144],"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.",[147,148,149,150],"Small Cell Lung Carcinoma","Large Cell Neuroendocrine Carcinoma of the Lung","Neuroendocrine Prostate Cancer","Gastroenteropancreatic Neuroendocrine Carcinoma",[152,153,154,155,156,157,158,159,160],"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","2026-05-04",{"date":163,"type":164},"2026-05-05","ACTUAL",{"date":166,"type":164},"2025-10-16",{"date":168,"type":141},"2031-08-29",{"name":28,"class":6},6]