A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

Open to males ages 18 years and up

• Pathologically confirmed prostatic adenocarcinoma.
• History of metastatic disease.
• Chemically or surgically castrate.
• Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
• Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate [eGFR] ≥ 50 mL/min, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], hemoglobin [Hgb] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm³ (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count [ANC] ≥ 1500 / mm³).

• Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
• History of neuroendocrine differentiation in the subject's disease.
• Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
• Subject has clinically significant CNS pathology.
• Subject requires chronic immunosuppressive therapy.
• Subject has a history of major cardiac abnormalities.