Background: Olaratumab is a human IgG1 monoclonal antibody that specifically binds human platelet-derived growth factor receptor (PDGFR)-α and blocks PDGF-mediated signaling pathways. Increased PDGFRα expression is observed in pancreatic cancer tissue, and has been suggested to play a role in the mesenchymal transition of pancreatic cancer. An ongoing trial designed to evaluate the safety and efficacy of olaratumab in combination with nab-paclitaxel/gemcitabine (nPG) in patients with unresectable metastatic pancreatic cancer not previously treated for metastatic disease is currently being conducted. Methods: JGDP (NCT03086369) is a global Phase 1b/Phase 2 study being conducted to evaluate the safety and efficacy of olaratumab in combination with nPG as first-line therapy in patients with Stage IV pancreatic cancer (ECOG PS ≤1). In the Phase 1b portion of the study, patients will receive intravenous (iv) olaratumab following a 3+3 dose escalation scheme at two different schedules: on Days 1, 8 and 15 at doses of 15 mg/kg and 20 mg/kg, or on Days 1 and 15 at 20 mg/kg and 25 mg/kg. Olaratumab will be given in combination with nPG (125 mg/m² iv/1000 mg/m² iv) on Days 1, 8, and 15 of a 28-day cycle. After the maximum tolerated dose has been identified, additional patients will be enrolled in a cohort expansion to confirm the safety of the combination prior to proceeding to the Phase 2 portion of the study. In the Phase 2 study, approximately 162 patients will be randomized at a 1:1 ratio to receive olaratumab at the recommended Phase 2 dose regimen or placebo, both in combination with nPG (125 mg/m² iv/1000 mg/m² iv). Treatment will continue until disease progression or other discontinuation criteria are met. The primary end point of the Phase 2 study is overall survival; a 2-sided α level of 0.20 will be applied. Assuming OS HR = 0.67, there is ≥80% power to show a significant difference in OS between study arms. Secondary end points include progression free survival, duration of response, objective response rate, patient-reported outcomes, and safety. As of September 2017, enrollment for the Phase 1b study is currently ongoing. Clinical trial information: NCT03086369