First-In-Human, Phase I Study Assessing Imalumab (Bax69), A First-In-Class Anti-Oxidized Macrophage Migration Inhibitory Factor (Oxmif) Antibody In Advanced Solid Tumors.

2518 Background: MIF is a pleiotropic cytokine involved in tumor proliferation, invasiveness, angiogenesis, and the proinflammatory microenvironment. oxMIF is the pathogenic form mainly in tumor and its surrounding stroma. Imalumab (Bax69) is a novel recombinant, fully-human, monoclonal antibody that targets oxMIF, inhibiting tumorigenesis. Preclinical data demonstrated that Imalumab has antitumor activities and acceptable toxicities. Methods: The primary endpoint of this dose-escalation study (3+3 design) was to assess maximum tolerated dose (MTD). The secondary endpoints were to assess antitumor activity, safety, pharmacokinetics (PK), and pharmacodynamics (PD). Patients (pts) received intravenous (IV) Imalumab [28-d cycles; 2 dose schedules (DS)]: biweekly in all solid tumors (DS1); weekly in metastatic colorectal cancer (mCRC) (DS2). Results: As of Dec 2014, 28 pts were analyzed. DS1 = 19pts in 6 cohorts (1, 3, 10, 25, 37.5, and 50 mg/kg), and DS2 = 9 pts in 2 cohorts (10u0026 25 mg/kg). AUC and Cmaxincre...