A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAffibody
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- [177Lu]Lu-ABY-271
Treatment groups
21 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov