Actively Recruiting
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
Led by Affibody · Updated on 2025-10-01
21
Participants Needed
3
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and distribution of a drug called [177Lu]Lu-ABY-271 in people with HER2-positive metastatic breast cancer. This early phase 1 trial aims to understand how the drug behaves in tumors and key organs, helping to guide future treatments. The study is open-label and randomized, involving female participants aged 18 and older with advanced breast cancer confirmed by specific tests. The trial has two parts. Part A will enroll up to 6 participants to study how the drug is absorbed by tumors and critical organs after a single infusion. Part B will include 15 participants divided into three groups, each receiving a different protein mass dose with varying radioactivity levels, to determine the best dose for future studies. Treatments are given as a single infusion of [177Lu]Lu-ABY-271. Participants will be closely monitored through assessments of side effects and dose-limiting toxicities up to 29 days for Part A and 43 days for Part B. Researchers will also measure radiation absorbed by organs and tumors within 8 days after treatment. The study includes regular evaluations of tumor size, health status, and overall safety. The total participation time varies depending on the study part and dosing schedule.
CONDITIONS
Brief 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...
- Female subjects with unresectable locally advanced or metastatic breast cancer
- Histologically or cytologically confirmed carcinoma with documented HER2 overexpression (IHC score 3+ or 2+ with ISH positive, biopsy not older than 2 years)
- At least one known tumor lesion 15 mm or larger
- ECOG performance status of 2 or less
- For Part A only: currently in treatment or planned to start a new line of standard systemic anti-tumor therapy
- For Part B only: progressive disease documented radiologically in the last 3 months
- For Part B only: received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting
- For Part B only: no ongoing treatment-related toxicities above grade 1 (except alopecia) before first dose of [177Lu]Lu-ABY-271
You will not qualify if you...
- Active brain metastases
- Use of another investigational medicinal product within 5 half-lives (or 6 months for experimental biologics) before planned first dose of [177Lu]Lu-ABY-271
- Exposure to 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks depending on trial part
Participants receive a single infusion of [177Lu]Lu-ABY-271 to assess safety, tolerability, and biodistribution.
Multiple visits for assessments up to Day 29 for Part A and Day 43 for Part B
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
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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