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