First human use of [177Lu]Lu-ABY-271 to target 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
This first-in-human Phase 1 test will see if the radiopharmaceutical [177Lu]Lu-ABY-271 is safe and how it distributes in the body for people with HER2-positive metastatic breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Affibody Industry-sponsored |
| Locations | 3 sites (Gothenburg and 2 other locations) |
| Trial ID | NCT07081555 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable locally advanced or metastatic HER2-positive breast cancer, an ECOG ≤2 and at least one measurable lesion ≥15 mm, with Part B reserved for those with recent progression after ≥3 prior systemic therapies.
Not a fit: Patients with HER2-negative disease, active untreated brain metastases, poor performance status (ECOG >2), very small lesions, or ongoing significant toxicities from prior therapy are unlikely to benefit.
Why it matters
Potential benefit: If successful, this agent could deliver targeted radiation to HER2-positive tumors and potentially control disease while limiting exposure to healthy organs.
How similar studies have performed: Lutetium-177 targeted radiotherapies have proven effective in other cancers and early-phase HER2-targeted radiopharmaceutical and affibody imaging work has been promising, but [177Lu]Lu-ABY-271 is being tested in humans for the first time.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Gothenburg and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.