A Phase I Study of AMG 509 in Men with Advanced Prostate Cancer

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Full Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects 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).

 In this study, researchers want to find the highest dose of the investigational drug AMG 509 that can be used safely in patients with CRPC. AMG 509 is a bispecific antibody that binds to two different proteins; one found on the surface of cancer cells and one on the surface of T cells in the immune system. Researchers think that AMG 509 may strengthen the immune system’s ability to fight cancer cells. It 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 has continued to grow despite abiraterone and/or enzalutamide and at least one (but no more than two) regimens of taxane chemotherapy.
  • At least 4 weeks must pass between the completion of prior treatment and receipt of AMG 509.
  • 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. Daniel Danila at 646-422-4612.

Protocol

20-294

Phase

I

Investigator

Co-Investigators