A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer

Exclusion Criteria

• •History of central nervous system metastasis, including incompletely treated epidural disease
• •History of other primary malignancy (including premalignant myeloid malignancy e.g. myelodysplastic syndrome), unless:
• •* Curatively resected non-melanomatous skin cancer
• •* Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
• •Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outsubject medication
• •The following treatments are not allowed within 4 weeks of enrollment: cytotoxic chemotherapy, radiation therapy or the dietary supplement PC-SPES
• •Use of prednisone (or equivalent corticosteroids) \> 20 mg/day are not allowed. Doses \< 20 mg/day are allowed only if they have been at the same dose for \> 4 weeks
• •Use of anti-androgen therapy (ie, flutamide, bicalutamide and nilutamide) within 6 weeks of study enrollment; non-responders to second-line anti-androgen therapy do not require the 6 week withdrawal period
• •Monoclonal antibody therapy within 3 months of enrollment with the exception of denosumab (prior or concurrent use of denosumab is allowed)
• •Peripheral neuropathy of ≥ grade 2 as defined by the CTCAE criteria version 4.0
• •Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
• •Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
• •Use of any investigational drug (including marketed drugs not approved for this indication) within 30 days prior to enrollment
• •History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE))
• •Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen