A Phase II Study of IMMU-132 in Men with Metastatic Castration-Resistant Prostate Cancer that Worsened During Hormone Therapy

Full Title

A Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of IMMU-132 in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed Therapy

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 assess the safety and effectiveness of the investigational drug sacituzumab govitecan (IMMU-132) in men with metastatic CRPC that continued to grow while they were taking hormonal therapy such as abiraterone, enzalutamide, or apalutamide. IMMU-132 is a chemotherapy drug attached to an antibody. The antibody in IMMU-132 binds to a type of cancer-causing cell and stops the cell’s ability to grow. 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 metastatic CRPC and evidence of continued cancer growth while taking hormonal therapy with abiraterone, enzalutamide, or apalutamide.
  • Patients may not have received chemotherapy for CRPC.
  • 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. Susan F. Slovin at 646-422-4470.

Protocol

18-533

Phase

II

Investigator

Co-Investigators