NCT07081555 A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
| NCT ID | NCT07081555 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Affibody |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2025-10-06 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07081555 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07081555 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07081555 currently recruiting?
Yes, NCT07081555 is actively recruiting participants. Contact the research team at ABY-271-101@affibody.se for enrollment information.
Where is the NCT07081555 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT07081555 clinical trial?
NCT07081555 is sponsored by Affibody. The trial plans to enroll 21 participants.
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