Safety and pharmacokinetics of intravenous VEGF Trap in a phase I clinical trial of patients with advanced solid tumors

3029 Background: VEGF Trap is a potent angiogenesis inhibitor comprising portions of human VEGF receptor VEGFR1 (Flt-1) and VEGFR2 (KDR) extracellular domains fused to the Fc portion of human IgG. VEGF Trap binds VEGF-A and neutralizes all VEGF-A isoforms plus placental growth factor. This study was designed to evaluate the safety and pharmacokinetics (PK) of VEGF Trap administered intravenously. Methods: Successive cohorts of patients (pts) with relapsed or refractory solid tumors received intravenous VEGF Trap on Days 1 and 15. Pts without dose-limiting toxicity subsequently entered a long-term extension study. Study endpoints included safety, PK, and immunogenicity. Antitumor activity was assessed by CT scan, and tumor vascular response was assessed by DCE-MRI. Results: Sixteen pts have been treated across 3 dose levels (0.3, 1.0, 2.0 mg/kg every 2 weeks) to date. In the 10 pts treated at the first 2 dose levels, the most common adverse events (AEs) were fatigue (n=9), pain (n=4), and constipation (n=4...