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Breast Cancer Trial Advances with Promising Early Results
17 Dec, 2025
Summary
- Trial Review Committee recommends advancing ABY-271 to Phase I trial second part.
- Therapy demonstrated targeted tumor activity and low kidney uptake.
- Next phase will test higher radioactivity levels and additional doses.
Affibody's investigational radioligand therapy, ABY-271, has earned a recommendation from its Trial Review Committee to advance into the second part of its Phase I clinical trial. This progression is for patients diagnosed with HER2-positive metastatic breast cancer.
Initial patient data from the trial's first cohort revealed compelling results, including targeted tumor activity and notably low uptake in kidneys and other critical organs. These findings support the therapy's potential efficacy and safety profile.
The upcoming trial phase will involve testing higher radioactivity levels and additional doses of protein mass. Affibody anticipates submitting a protocol amendment to the European Medicines Agency to expedite this transition, aiming to commence the next stage in the first half of 2026.
