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Bayer Begins Phase I Trial of PSMA-Targeted Radionuclide Therapy in Prostate Cancer

NEW YORK – Bayer on Wednesday said it began treating advanced metastatic castration-resistant prostate cancer patients in a Phase I trial of its radionuclide therapy 225Ac-PSMA-Trillium (BAY 3563254).

BAY 3563254 is a prostate-specific membrane antigen (PSMA)-targeting small molecule radiopharmaceutical designed to deliver alpha particle radiation to the tumor. The first-in-human trial will include 118 previously treated prostate cancer patients with at least one PSMA-positive distant metastatic lesion. The study will include dose-escalation and dose-expansion phases.

In the dose-expansion phase of the study, researchers will split the study population into cohorts by their prior treatment, such as Novartis' radiopharmaceutical therapy Pluvicto (177Lu-PSMA-617), and according to whether they've gotten taxane-based chemotherapy since their tumors became castration resistant. Researchers will also explore BAY 3563254 as an imaging agent and measure the whole-body radioactivity of 225Ac-PSMA-Trillium.

"Targeted radionuclide therapy is a strategic pillar of precision oncology at Bayer, holding the promise to shift the treatment paradigm for patients, including those whose disease has developed resistance to other treatments," Dominik Ruettinger, head of research and early development for oncology at Bayer, said in a statement.