Safety Study of AMG 228 to Treat Solid Tumors

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors

The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.

Inclusion Criteria:

• Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
• Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

• Active autoimmune disease, history of autoimmune disease
• Treatment with immune modulators including
• Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
• Major surgery within 28 days of study day 1