A Study of MEDI-575 in Patients With Advanced Solid Malignancies

A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies

The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).

Inclusion Criteria:

• Having advanced solid malignancy for which no curative or standard therapies exist
• Karnofsky performance status of ≥60
• Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)

Exclusion Criteria:

• Inadequate bone marrow reserve or organ function
• Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
• History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody