A Phase I Study of EPI-7386 in Men with Advanced Prostate Cancer

Share
Print

Full Title

A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 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 testosterone-lowering 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 highest dose of the investigational drug EPI-7386 that can be given safely in men with metastatic CRPC. EPI-7386 works by interfering with the testosterone signaling that leads to the growth of prostate cancer. It is taken orally (by mouth).

Eligibility

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

  • Patients must have metastatic CRPC that has continued to grow despite at least two prior regimens of therapy for advanced cancer, including an anti-androgen therapy such as abiraterone, enzalutamide, apalutamide, or darolutamide.
  • Patients should recover from the serious side effects of previous treatments before receiving EPI-7386.
  • 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. Andrew Laccetti at 646-422-4683.

Protocol

21-008

Phase

I

Investigator

Co-Investigators