[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613057":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":111,"collaborators":21,"id":113,"slug":21,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":21,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":21,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":136,"overallStatus":37,"whyStopped":21,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Patients will receive 68Ga-NNS309 and only patients with tumor uptake will receive 177Lu-DFC413",[13,14],"Drug: 68Ga-NNS309","Drug: 177Lu-DFC413",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","68Ga-NNS309","Diagnostic investigational radiopharmaceutical",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"177Lu-DFC413","Therapeutic investigational radiopharmaceutical",[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",[35,49,59,69,79,89,97,106],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":21},"Novartis Investigative Site","RECRUITING","Montreal","Quebec","H3T 1E2","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-73.58781,45.50884,{"lat":47,"lon":46},{"facility":36,"status":37,"city":50,"state":21,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":21},"Odense C","5000","Denmark","DK",{"type":44,"coordinates":55},[56,57],10.39538,55.40841,{"lat":57,"lon":56},{"facility":36,"status":37,"city":60,"state":21,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":21},"Vandœuvre-lès-Nancy","54511","France","FR",{"type":44,"coordinates":65},[66,67],6.17114,48.66115,{"lat":67,"lon":66},{"facility":36,"status":37,"city":70,"state":21,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":21},"Essen","45147","Germany","DE",{"type":44,"coordinates":75},[76,77],7.01228,51.45657,{"lat":77,"lon":76},{"facility":36,"status":37,"city":80,"state":21,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":21},"Haifa","3109601","Israel","IL",{"type":44,"coordinates":85},[86,87],34.99928,32.81303,{"lat":87,"lon":86},{"facility":36,"status":37,"city":90,"state":21,"zip":91,"country":82,"countryCode":83,"cosmosGeoPoint":92,"geoPoint":96,"contacts":21},"Tel Aviv","6423906",{"type":44,"coordinates":93},[94,95],34.78057,32.08088,{"lat":95,"lon":94},{"facility":36,"status":37,"city":98,"state":21,"zip":99,"country":98,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":21},"Singapore","119228","SG",{"type":44,"coordinates":102},[103,104],103.85007,1.28967,{"lat":104,"lon":103},{"facility":36,"status":37,"city":98,"state":21,"zip":107,"country":98,"countryCode":100,"cosmosGeoPoint":108,"geoPoint":110,"contacts":21},"168583",{"type":44,"coordinates":109},[103,104],{"lat":104,"lon":103},{"type":112,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100613057",false,"NCT07261631","Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors","A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+\u002FHER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 100 x 109\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2, calculated using CKD-EPI 2021 or measured\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy\n* Any prior radioligand therapy\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-DFC413\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":123,"type":124},180,"ESTIMATED","INTERVENTIONAL",[127],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-DFC413 and safety and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors",[130,131,132,133,134,135],"Pancreatic Ductal Adenocarcinoma","Non-Small Cell Lung Cancer","HR+\u002FHER2- Ductal and Lobular Breast Cancer","Triple Negative Breast Cancer","Colorectal Cancer","Soft Tissue Sarcoma",[137,138,139,140,141,142],"PDAC","NSCLC","Breast cancer","CRC","STS","Radioligand therapy (RLT)","2026-06-16",{"date":145,"type":146},"2026-06-17","ACTUAL",{"date":148,"type":146},"2025-11-24",{"date":150,"type":124},"2029-05-09",{"name":28,"class":6},8]