[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601954":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":31,"responsibleParty":45,"collaborators":23,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":23,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":23,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":34,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Advanced breast cancer","EXPERIMENTAL","Patients will receive FKL480 (\\[68Ga\\]Ga-DWJ155)",[13],"Drug: [68Ga]Ga-DWJ155",{"label":15,"type":10,"description":11,"interventionNames":16},"Advanced NSCLC",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","[68Ga]Ga-DWJ155","Radioligand imaging agent",[15,9],null,[25,30],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Novartis Pharmaceuticals","CONTACT","+41613241111","novartis.email@novartis.com",{"name":26,"role":27,"phone":23,"phoneExt":23,"email":23},[32],{"facility":33,"status":34,"city":35,"state":23,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":23},"Novartis Investigative Site","RECRUITING","Groningen","9728","Netherlands","NL",{"type":40,"coordinates":41},"Point",[42,43],6.56667,53.21917,{"lat":43,"lon":42},{"type":46,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100601954","phase-1-a-phase-i-study-of-68gaga-dwj155-in-patients-with-breast-and-lung-cancers-100601954",false,"NCT07117214","A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers","A Phase I, Open Label First in Human Study to Evaluate the Imaging Performance, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Advanced Breast Cancer and Advanced NSCLC","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with histologically or cytologically confirmed and documented HR+\u002FHER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed\u002Frefractory (r\u002Fr) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy.\n* Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.\n\nExclusion Criteria:\n\n* Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol\n* Patients with inadequate hepatic function\n* Unmanageable urinary tract obstruction or urinary incontinence\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":58,"type":59},36,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive\u002FHER2 negative (HR+\u002FHER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.",[65,66],"Breast Neoplasms","Carcinoma, Non-Small-Cell Lung",[68,69,70,20,71,72,73,74,75,76,77],"Breast cancer","Non-small cell lung cancer","Radioligand imaging","FKL480","gallium","adenocarcinoma","ductal","lobular","positron emission tomography (PET)","dosimetry","2026-06-08",{"date":80,"type":81},"2026-06-09","ACTUAL",{"date":83,"type":59},"2026-06-01",{"date":85,"type":59},"2028-10-31",{"name":26,"class":6},1]