A Phase I Study of EPI-7386 in Combination with Enzalutamide to Treat Metastatic Prostate Cancer

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Full Title

A Phase 1/2 Study of EPI-7386 in Combination with Enzalutamide Compared with Enzalutamide Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer [EPI-7386-CS-010]

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 highest dose of the investigational drug EPI-7386 that can be given safely with enzalutamide in people with metastatic CRPC. EPI-7386 works by interfering with the function of the hormone system that leads to prostate cancer growth. Enzalutamide is a standard treatment for metastatic CRPC; it works by blocking the action of hormones like testosterone to slow down the growth of prostate cancer. Both medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have metastatic CRPC.
  • Patients may not have received “second-generation androgen synthesis inhibitors” such as abiraterone or androgen receptor signaling inhibitors such as enzalutamide, apalutamide, or darolutamide.
  • At least 4 weeks must pass since the completion of prior anticancer therapies (other than hormonal therapy, such as leuprolide) and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for men age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Andrew Laccetti at 646-422-4683.

Protocol

22-051

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators