RecruitingPhase 1NCT07081555
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
Sponsor
Affibody
Enrollment
21 participants
Start Date
Oct 6, 2025
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria10
- 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 Criteria3
- 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
- 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
Interventions
DRUG[177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07081555
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