First human use of [177Lu]Lu-ABY-271 to target HER2-positive metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, first-in-human Phase 1 effort has two parts to characterize safety, tolerability, and biodistribution of [177Lu]Lu-ABY-271 in HER2-positive metastatic breast cancer. Part A will sequentially enroll up to six subjects to measure tumor and critical-organ uptake and early safety signals. Part B will randomize 15 subjects across three protein mass dose levels (1:1:1) in two sequential cohorts with different radioactivity levels to identify an optimal protein mass dose for later trials. Key eligibility includes confirmed HER2 overexpression, at least one lesion ≥15 mm, and ECOG performance status ≤2, with Part B restricted to patients with recent radiologic progression and at least three prior systemic lines.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden Recruiting
• Akademiska Sjukhuset
  Uppsala, Sweden Recruiting

Study contacts

• Study coordinator: Affibody AB
• Email: ABY-271-101@affibody.se
• Phone: 46859883800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.