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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07081555 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any anti-tumor therapy, investigational medicinal product disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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 qualifyRelated pages