Study of BMS-663513 in Patients With Advanced Cancer

A Phase I/II, Ascending Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients With Metastatic or Locally Advanced Solid Malignancies

This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• Measurable disease.
• Absolute neutrophil count (ANC) >= 1,500 cells/mm3
• Platelet count >= 100K cells/mm3
• Hemoglobin >= 9.0 g/dL
• Total bilirubin <= 1.5 x IULN
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)
• Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma

Exclusion Criteria:

• History of autoimmune diseases.
• Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
• Active/symptomatic brain metastasis.
• History of hepatitis B or C.
• Concurrent malignancy.