A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer

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.

Trial Details

NCT ID
NCT07081555
Phase
PHASE1
Sponsor
Affibody
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • [177Lu]Lu-ABY-271
Locations (sample)
  • Gothenburg, Sweden|57.70716,11.96679
  • Stockholm, Sweden|59.32938,18.06871
  • Uppsala, Sweden|59.85882,17.63889

Key Eligibility 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): immunohistoch…
  • At least one known tumor lesion ≥ 15 mm
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

For full eligibility, visit ClinicalTrials.gov.

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