IRB #

STUDY00018878

Title

A phase 1 study of FOR46 administered every 21 days in patients with metastatic castration-resistant prostate cancer (mCRPC)

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to determine the side effects, good and/or bad, and the optimal recommended dose of an investigational drug called FOR46 sterile solution for injection in participants with metastatic castration resistant prostate cancer.

Another purposes of the study is to measure the effects of the study drug, its mechanism of action on tumor cells and 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 not have evidence of small-cell/neuroendocrine prostate cancer on prior biopsy.
- Subjects should have at least one prior treatment with the FDA approved androgen-signaling inhibitors therapy (eg, abiraterone, enzalutamide, apalutamide) in the castration-resistant setting
- Subjects should not have prior treatment with cytotoxic chemotherapy in metastatic castration-resistant setting
- Subjects should not have prior treatment with radium-223 or another radiopharmaceutical treatment
- Subjects should not have any history of brain metastases

Age Range

18 - NA

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the investigational drug until their cancer gets worse or they experience unacceptable side effects. There will be one follow up visit 30 days after the last dose of the study drug. After discontinuation of the study drug, participants will be contacted via a phone call at about 3 months and 6 months after the last dose of study drug.

Minors Included

No

Contact

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

Sponsor

Fortis Therapeutics, Inc

Recruitment End

12/31/2020

Compensation Provided

No


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