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.
• 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