A Study of FOR46 Given Every 21 Days for the Treatment of Your Prostate Cancer

Fortis Study

Lay Title: A study of FOR46 Given Every 21 days for the Treatment of Your Prostate Cancer

Technical Title: A Phase 1 Study of FOR46 Administered Every 21 Days in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Disease Type: Metastatic, castration-resistant prostate cancer

Basic information: The purpose of this study is to learn more about the safety and anticancer activity of the study drug, named FOR46, which is being developed to see if it can treat metastatic prostate cancer. FOR46 is made up of an antibody (a type of protein) and an anticancer drug. It is designed to travel through the bloodstream throughout the body and find cancer cells, and ultimately kill them or delay cancer growth. It is given to patients through the vein (intravenously, or IV).

Research Procedures (not a complete list): You will receive FOR46 on the first day of each 21-day treatment cycle. For the first two cycles, you will come to clinic several times per week the first week and once during the second week for other assessments, such as laboratory tests, cardiac tests, and eye exams. After the first two cycles, the study team will try to schedule your assessments to occur on the same day as your treatment.

Eligibility Criteria (not a complete list):

Inclusion Criteria:

• Diagnosis of metastatic, castration-resistant prostate cancer (mCRPC)
• Prostate cancer did not respond to at least one antiandrogen therapy (abiraterone, enzalutamide, or apalutamide) 

Exclusion Criteria:

• No significant peripheral neuropathy or genetic disorders associated with peripheral neuropathy
• No prior treatment with chemotherapy for mCRPC
• No previous treatment with drugs targeting CD46, or with radium-223 (Xofigo) or other radiopharmaceuticals
• No HIV; no active or chronic hepatitis B or C

For More Detailed Information, Contact:

• Matthew Rettig, MD, Principal Investigator
• Colleen Mathis, Study Coordinator, (310) 794-2731