First-in-human phase I/II dose-escalation study of IMAB027 in patients with recurrent advanced ovarian cancer (OVAR): Preliminary data of phase I part.

5537 Background: Ovarian cancer (OC) is a high medical need disease. Most patients (pts) relapse following initial therapy with limited therapeutic options. IMAB027 is the first-in-class monoclonal antibody (mAB) directed against claudin 6 (CLDN6), a cancer cell specific, embryonic tight junction protein and cancer stem cell marker. CLDN6 is expressed in > 55% of OCs and frequently in other cancer types. In preclinical models, IMAB027 executes potent anti-tumor activity via AB-dependent cellular cytotoxicity and complement-dependent cytotoxicity without mediating off-target toxicity. Methods: This first-in-human, open-label, dose escalation Phase I/II trial assesses the safety/tolerability (NCI-CTCAEv4.0), pharmacokinetics (PK) and clinical efficacy (RECIST 1.1) of IMAB027 in pts with advanced, recurrent CLDN6+ OC. Here we report preliminary data on 12 pts enrolled in the Phase I part of the study as of August 15, 2014. Pts received 100, 300, 600, or 1000 mg/m2 IMAB027 (n = 3/group) q3w IV until disease p...