[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599212":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":71,"collaborators":32,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":32,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":32,"enrollmentInfo":82,"targetDuration":32,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Affibody","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A","EXPERIMENTAL","\\[177Lu\\]Lu-ABY-271",[13],"Drug: [177Lu]Lu-ABY-271",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B - Cohort 1","\\[177Lu\\]Lu-ABY-271 with protein mass dose A",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part B - Cohort 2","\\[177Lu\\]Lu-ABY-271 with protein mass dose B",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part B - Cohort 3","\\[177Lu\\]Lu-ABY-271 with Protein mass dose C",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","[177Lu]Lu-ABY-271","A single infusion of \\[177Lu\\]Lu-ABY-271",[9,15,19,23],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Affibody AB","CONTACT","46859883800","ABY-271-101@affibody.se",[40,53,62],{"facility":41,"status":42,"city":43,"state":32,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":32},"Sahlgrenska University Hospital","RECRUITING","Gothenburg","S-413 45","Sweden","SE",{"type":48,"coordinates":49},"Point",[50,51],11.96679,57.70716,{"lat":51,"lon":50},{"facility":54,"status":42,"city":55,"state":32,"zip":56,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":32},"Karolinska University Hospital","Stockholm","SE-17164",{"type":48,"coordinates":58},[59,60],18.06871,59.32938,{"lat":60,"lon":59},{"facility":63,"status":42,"city":64,"state":32,"zip":65,"country":45,"countryCode":46,"cosmosGeoPoint":66,"geoPoint":70,"contacts":32},"Akademiska Sjukhuset","Uppsala","SE-751 85",{"type":48,"coordinates":67},[68,69],17.63889,59.85882,{"lat":69,"lon":68},{"type":72,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100599212","phase-1-a-first-in-human-phase-1-safety-and-biodistribution-of-177lulu-aby-271-in-subjects-with-her2-positive-metastatic-breast-cancer-100599212",false,"NCT07081555","A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer","A First-in-Human Phase 1, Open-label, Two-stage, Randomized Trial to Assess the Safety, Tolerability, and Biodistribution of [177Lu]Lu-ABY-271 in Tumors and Critical Organs in Subjects With HER2-positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subject has unresectable locally advanced or metastatic breast cancer\n* Subject with histologically or cytologically confirmed carcinoma with documented HER2 overexpression (biopsy not older than 2 years): immunohistochemistry (IHC) score 3+; OR 2+ and fluorescence in situ hybridization (ISH) positive\n* At least one known tumor lesion ≥ 15 mm\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n\nPart A only\n\n\\- Subject is in treatment, or planned to start a new line of standard systemic anti-tumor therapy\n\nPart B only\n\n* Subject has progressive disease, documented radiologically in the last three months\n* Subject has received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting\n* Subject has received last dose of previous line of systemic anti-tumor therapy, and has no ongoing treatment related toxicities \\> grade 1 (except alopecia) prior to planned first dose of \\[177Lu\\]Lu-ABY-271\n\nExclusion Criteria:\n\n* Active brain metastases\n* Administration of another IMP within 5 half-lives (for experimental biologics: 6 months or 5 half-lives, whichever is longer) of the planned first dose of \\[177Lu\\]Lu-ABY-271\n* Exposure to any anti-tumor therapy since the last documented progression, including any radiotherapy within 7 days prior to the planned first dose of \\[177Lu\\]Lu-ABY-271","FEMALE","18 Years",{"count":83,"type":84},21,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","This is a FiH phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of \\[177Lu\\]Lu-ABY-271 in subjects with HER2 positive metastatic breast cancer.",[90,91],"Metastatic Breast Cancer","HER2 + Breast Cancer",[93,94,95,96,97],"Radiopharmaceutical","Biodistribution","First-in-human","phase 1","safety","2025-09-30",{"date":100,"type":101},"2025-10-01","ACTUAL",{"date":103,"type":84},"2025-10-06",{"date":105,"type":84},"2028-06-01",{"name":5,"class":6},3]