Actively Recruiting
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
Led by Affibody · Updated on 2025-10-01
21
Participants Needed
3
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has unresectable locally advanced or metastatic breast cancer
- Subject has histologically or cytologically confirmed carcinoma with documented HER2 overexpression (IHC score 3+ or 2+ with positive ISH), biopsy no older than 2 years
- Subject has at least one known tumor lesion 15 mm or larger
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- For Part A only: Subject is receiving or plans to start a new standard systemic anti-tumor therapy
- For Part B only: Subject has progressive disease documented by imaging in the last 3 months
- For Part B only: Subject has received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting
- For Part B only: Subject has completed previous systemic therapy with no ongoing toxicities above grade 1 (except alopecia) before first dose of [177Lu]Lu-ABY-271
You will not qualify if you...
- Active brain metastases
- Received another investigational medicinal product within 5 half-lives (or 6 months for biologics) before planned first dose of [177Lu]Lu-ABY-271
- Received any anti-tumor therapy since last documented progression, including radiotherapy within 7 days before planned first dose of [177Lu]Lu-ABY-271
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Actively Recruiting
2
Karolinska University Hospital
Stockholm, Sweden, SE-17164
Actively Recruiting
3
Akademiska Sjukhuset
Uppsala, Sweden, SE-751 85
Actively Recruiting
Research Team
A
Affibody AB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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