This study is a Phase 1a and 1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and PD of FPA008 as monotherapy and in combination with nivolumab in patients with selected advanced cancers. FPA008 is a humanized monoclonal antibody directed against CSF1R and nivolumab is a fully human monoclonal antibody directed against PD-1. For the combination arms of the study, FPA008 and nivolumab will be given on Day 1 of each 14-day treatment cycle. Nivolumab will be administered as an IV infusion over 30 minutes followed by a 30-minute rest, and then FPA008 will be administered as an IV infusion over 30 minutes.
The study will include a Phase 1a dose escalation and a Phase 1b dose expansion. Phase 1a consists of 2 planned FPA008 monotherapy reference cohorts (1aM1 and 1aM2) and 3 planned cohorts of FPA008 in combination with nivolumab (1aC1, 1aC2, and 1aC3). Phase 1b consists of 8 cohorts (1b1 through 1b8) across 6 cancer types. Patients will be enrolled into either Phase 1aM, 1aC, or Phase 1b of the study.