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Amgen’s AMG 509 Study: A Potential Game-Changer in Prostate Cancer Treatment

Amgen’s AMG 509 Study: A Potential Game-Changer in Prostate Cancer Treatment

Amgen Inc ((AMGN)), BeOne Medicines ((ONC)) announced an update on their ongoing clinical study.

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Amgen Inc., in collaboration with BeiGene and BeOne, is conducting a Phase 1 clinical study titled ‘A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer.’ The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMG 509, both as a monotherapy and in combination with other drugs, in patients with metastatic castration-resistant prostate cancer (mCRPC).

The study is testing AMG 509, a drug administered either intravenously or subcutaneously, alone or in combination with abiraterone acetate and enzalutamide. These interventions are intended to improve treatment outcomes for patients with mCRPC.

This interventional study is randomized, with a sequential intervention model and no masking, primarily focused on treatment. The study is designed to explore different dosing regimens and combinations to determine the maximum tolerated dose and recommended phase 2 dose.

The study began on December 16, 2019, with the primary completion date yet to be announced. The latest update was submitted on October 22, 2025. These dates are crucial for tracking the study’s progress and any emerging data that may impact future treatment protocols.

The ongoing study could significantly influence Amgen’s stock performance, as positive results may enhance investor confidence and market position, especially in the competitive oncology sector. The involvement of BeiGene and BeOne highlights the collaborative efforts in advancing cancer treatment.

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

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