A Phase I Study of EC1169 in Men with Recurrent Metastatic Castration-Resistant Prostate Cancer

Full Title

A Phase 1 Study of a Prostate-Specific Membrane Antigen Targeting-Tubulysin Conjugate EC1169 in Patients with Recurrent Metastatic, Castration-Resistant Prostate Cancer (mCRPC)

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 (and are called "castration-resistant" prostate cancer, or CRPC). Additional hormonal therapies (enzalutamide and abiraterone) and chemotherapy drugs (docetaxel and cabazitaxel) are treatments for CRPC, but the cancer often eventually grows despite these therapies as well.

EC1169 is an investigational chemotherapy drug that works similarly to docetaxel and cabazitaxel. Unlike those drugs, however, it specifically targets the prostate cancer cell using a protein called prostate-specific membrane antigen. The purpose of this study is to find the highest dose of EC1169 that can be given safely in men with CRPC and to see how the drug is processed in the body. EC11169 is given intravenously.

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 continued to grow despite treatment with enzalutamide and/or abiraterone and has also grown despite treatment with docetaxel and/or cabazitaxel.
  • At least 4 weeks must pass between completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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

15-077

Phase

I

Investigator

Locations