Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Bayer AG is conducting a first-in-human clinical study titled ‘A Phase 1 Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of 225Ac-PSMA-Trillium in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)’. The study aims to find a more effective treatment for mCRPC, a type of prostate cancer that has spread and is resistant to hormone therapy. The primary objectives are to assess the safety, determine the optimal dose, and evaluate the antitumor activity of the investigational drug 225Ac-PSMA-Trillium.
The intervention being tested is 225Ac-PSMA-Trillium, also known as BAY3563254. This drug is designed to target and bind to PSMA, a protein found on prostate cancer cells, and emit radiation to damage and inhibit the growth of these cells.
The study is interventional with a non-randomized, sequential model. It is open-label, meaning both the researchers and participants know what treatment is being administered. The primary purpose of the study is treatment-focused, aiming to establish the safety and efficacy of the drug.
The study began on March 7, 2024, with an estimated primary completion date yet to be determined. The last update was submitted on July 14, 2025. These dates are crucial for tracking the study’s progress and anticipating future developments.
This study could have significant market implications for Bayer AG, potentially boosting its stock performance if the results are favorable. Positive outcomes could enhance investor confidence and position Bayer competitively within the oncology market, particularly against other firms developing prostate cancer treatments.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.