NCT07081555 A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
| NCT ID | NCT07081555 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Affibody |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-01-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Active brain metast
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