OncoMatch/Clinical Trials/NCT07081555
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
Is NCT07081555 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies [177Lu]Lu-ABY-271 for metastatic breast cancer.
Treatment: [177Lu]Lu-ABY-271 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+ and ish positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anti-tumor therapy — palliative
received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting
Cannot have received: any anti-tumor therapy
Exception: since the last documented progression
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
Cannot have received: investigational medicinal product
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify