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A First-in-Human Phase 1, Open-label, Two-stage, Randomized Trial to Assess the Safety, Tolerability, and Biodistribution of [177Lu]Lu-ABY-271 in Tumors and Critical Organs in Subjects With HER2-positive Metastatic Breast Cancer

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Trial Profile

A First-in-Human Phase 1, Open-label, Two-stage, Randomized Trial to Assess the Safety, Tolerability, and Biodistribution of [177Lu]Lu-ABY-271 in Tumors and Critical Organs in Subjects With HER2-positive Metastatic Breast Cancer

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Dec 2025

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At a glance

  • Drugs Lutetium-177-ABY-271-Affibody (Primary)
  • Indications Advanced breast cancer; Carcinoma; HER2 positive breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Affibody

Most Recent Events

  • 16 Dec 2025 According to Affibody AB Media Release, company will submit a protocol amendment to the European Medicines Agency (EMA) to accelerate the transition to the second part, which is expected to start in first half of 2026 with the first results anticipated in second half of 2026.
  • 16 Dec 2025 According to Affibody AB Media Release, company announced that the Trial Review Committee (TRC) has recommended to advance the Phase I clinical study with the Radioligand Therapy (RLT) candidate ABY-271 in HER2-positive metastatic breast cancer to its second part, where higher radioactivity levels will be evaluated.
  • 16 Dec 2025 Initial results presented in the Affibody AB Media Release.

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