A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Inclusion Criteria:

• Good activity level
• Life expectancy of ≥ 6 months
• Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria:

• Major surgery within 4 weeks
• Any concurrent cancer
• History of autoimmune diseases
• Symptomatic bowel obstruction
• Continued use of steroids
• Symptomatic brain metastases
• Current nerve damage in fingers/toes
• Positive for HIV, hepatitis B/C
• White blood cells < 3,000
• Hemoglobin < 9
• Platelets < 100,000
• ALT/AST and/or alkaline phosphatase >= 2.5 x ULN
• Creatine > 1.5
• Prior BMS-663513