AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.

Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.

Inclusion Criteria:

• Patient has hormone-refractory metastatic prostate cancer

Exclusion Criteria:

• Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects
• Patient is currently participating or has participated in an investigational study within the past 30 days
• Patient has illness or circumstance that could limit compliance with the study requirements
• Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year
• Patient has Hepatitis B or C