A phase I pharmacokinetic (PK) study of MBP-426, a novel liposome encapsulated oxaliplatin

2535 Background: MBP-426 is a novel liposome encapsulated oxaliplatin (L-OHP) formulation bound to human transferrin, developed to improve the safety and efficacy of L -OHP through the prolongation of circulation time and by targeting transferrin receptors on tumor cells. In vitro, MBP-426 is effective against various human cancer cell lines. This study assessed the toxicity and safety of intravenously (IV) administered MBP-426, including defining the maximally tolerated dose (MTD), dose-limiting toxicities (DLTs), and pharmacokinetics (PKs). Methods: Patients (pts) with advanced/ metastatic solid tumors refractory to conventional therapy received MBP-426 as 2–4 hrs IV infusion every 3 weeks in cohorts of 3 to 6 pts. Enrollment required age > 18 yrs, ECOG Performance Status 0–2 and adequate organ functions. Tumor response was assessed by RECIST. Plasma was sampled for PK. Results: 39 pts were dosed, median age 59 (range 27–79), 25 (64%) male. The common tumor types were colorectal 23 (60%), pancreas 3 (8%...