Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Bayer AG has launched 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 novel treatment BAY3546828 for patients with advanced metastatic castration-resistant prostate cancer, a condition where the cancer has spread and is resistant to hormone therapy. This study is significant as it explores a new therapeutic option for a challenging cancer type.
The intervention under investigation is Actinium-225-macropa-pelgifatamab (BAY3546828), a drug designed to target prostate-specific membrane antigen (PSMA) on cancer cells. It emits radiation that kills nearby cancer cells, offering a potential new treatment for patients who have limited options.
The study employs an interventional, non-randomized, sequential model with no masking, focusing primarily on treatment. It consists of two parts: dose escalation to determine the optimal dose, followed by dose expansion to further evaluate efficacy and safety.
The study began on September 20, 2023, and is currently recruiting participants. The primary completion and estimated study completion dates are set for August 7, 2025, with the last update submitted on the same date. These timelines are crucial for tracking the study’s progress and potential market entry.
The outcome of this study could significantly impact Bayer’s stock performance and investor sentiment, as successful results may position BAY3546828 as a leading treatment for mCRPC. This could also influence the competitive landscape, prompting responses from other pharmaceutical companies in the oncology sector.
The study is ongoing, with further details available on the ClinicalTrials portal.