A Phase I Study of JNJ-69086420 for Advanced Prostate Cancer

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Full Title

A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced 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 JNJ-69086420 that can be given safely in men with metastatic CRPC. JNJ-69086420 is called “targeted alpha therapy.” It consists of an antibody that targets prostate cancer cells, attached to a radioactive particle which gives off a small amount of radiation to kill the cancer cells. JNJ-69086420 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 that continues to grow despite prior treatment with at least one novel androgen receptor-targeted therapy (such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide).
  • Patients may not have previously received radiation therapy or any radiation-based treatment.
  • 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 patients 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

21-070

Phase

I

Investigator

Co-Investigators