Bayer’s Innovative Approach in Prostate Cancer Treatment: A Phase 1 Study Update

Bayer AG ((BAYRY)) announced an update on their ongoing clinical study.

Bayer AG is conducting a Phase 1 clinical study titled A Phase 1 Open-label, First-in-human, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Actinium-225-macropa-pelgifatamab (BAY 3546828) in Participants With Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC). The study aims to assess the safety and efficacy of the drug BAY3546828 in treating advanced metastatic castration-resistant prostate cancer, a condition where prostate cancer spreads and resists standard hormone-lowering treatments.

The intervention being tested is Actinium-225-macropa-pelgifatamab, also known as BAY3546828. This drug targets prostate-specific membrane antigen (PSMA) on cancer cells, emitting radioactivity to kill these cells, offering a novel approach for patients with limited treatment options.

The study is designed as an interventional, non-randomized, sequential model with no masking. Its primary purpose is treatment, focusing on determining the optimal dose and assessing the drug’s anticancer activity.

The study began on September 7, 2023, and is currently recruiting participants. The primary completion and estimated study completion dates are not specified, but the last update was submitted on October 13, 2025. These dates are crucial for tracking the study’s progress and potential market entry.

This study update could positively impact Bayer’s stock performance by showcasing its commitment to innovative cancer treatments. Success in this study may enhance investor confidence and position Bayer competitively in the oncology market, particularly against other companies developing PSMA-targeted therapies.

The study is ongoing, with further details available on the ClinicalTrials portal.