Tests a radioactive HER2-targeting drug in HER2-positive metastatic breast cancer
Tests a radioactive HER2-targeting drug in adults with spread of HER2-positive breast cancer.
Plain-language title generated from the registry record
Registry title: A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
Key facts
- Where
- Gothenburg, Stockholm, and Uppsala, SwedenSee the 3 sites
- Phase
- Phase 1
Where in Sweden
- Sahlgrenska University HospitalGothenburg, SwedenTaking people
- Karolinska University HospitalStockholm, SwedenTaking people
- Akademiska sjukhusetUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Affibody
- Trial code
- NCT07081555
- Record updated
- 1 October 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subject has unresectable locally advanced or metastatic breast cancer; 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; At least one known tumor lesion ≥ 15 mm; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; Part A only; Subject is in treatment, or planned to start a new line of standard systemic anti-tumor therapy; Part B only; Subject has progressive disease, documented radiologically in the last three months; Subject has received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting; 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.
Exclusion: 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; Active brain metastases; 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.