A Study of Radioactive BAY 2315497 for Metastatic Castration-Resistant Prostate Cancer

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Full Title

A Phase 1, Open-Label, First-in-Human, Multi-Center, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of a Thorium-227 Labeled Antibody-Chelator Conjugate, BAY 2315497 Injection, in Patients with Metastatic Castration Resistant Prostate Cancer

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).

The purpose of this study is to find the best dose of the investigational drug BAY 2315497 to give to men with CRPC. BAY 2315497 is a type of treatment called “targeted alpha therapy.” It uses an antibody (a protein that attaches to a protein on prostate cancer cells called PSMA) to deliver a radioactive particle directly to cancer cells. BAY 2315497 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have CRPC that continues to grow despite hormone therapy and chemotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Morris at 646-422-4469.

Protocol

20-333

Phase

I

Investigator

Co-Investigators