[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Affibody\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":19,"type":20},21,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Metastatic Breast Cancer","HER2 + Breast Cancer",[29,30,31,32,33],"Radiopharmaceutical","Biodistribution","First-in-human","phase 1","safety","RECRUITING","2025-09-30",{"date":37,"type":38},"2025-10-01","ACTUAL",{"date":40,"type":20},"2025-10-06",{"date":42,"type":20},"2028-06-01",{"name":44,"class":45},"Affibody","INDUSTRY",3,""]