IRB #

STUDY00016294

Title

Phase 1 Safety and Tolerability Study of ZEN003694 in Combination with Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer (ZEN003694-002)

Principal Investigator

Joshi Alumkal

Study Purpose

The purpose of this study is to determine the side effects, good and/or bad, and the highest dose of an investigational drug called ZEN003694 when given in combination with enzalutamide, a FDA approved treatment for metastatic castration resistant prostate cancer, in participants with metastatic castration resistant prostate cancer. Another purpose of the study is to determine how the body processes and gets rid of the study drug.

Medical Condition(s)

Metastatic castration resistant prostate cancer (mCRPC)

Eligibility Criteria

- Subjects should have metastatic castration-resistant prostate cancer
- Subjects should have recent disease progression after treatment with the FDA approved anti-androgen therapy (abiraterone or enzalutamide)
- Subjects should not have previous treatment with chemotherapy in metastatic castration-resistant setting
- Subjects should not have any history of brain metastasis or conditions predisposing to seizure

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the investigational drug and enzalutamide until their cancer gets worse or they experience unacceptable side effects. There will be one final safety visit 30 days after discontinuation of the study drugs.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Zenith Epigenetics Corp.

Recruitment End

12/31/2025

Compensation Provided

No


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