546P Phase I study with expansion cohorts to assess the safety, tolerability, and activity of oral paclitaxel (oPac) + encequidar (E) in combination with pembrolizumab (Pem) in subjects with advanced solid malignancies

Abstract

The combination of IV Pac + Pem has demonstrated preliminary antitumor activity in two NSCLC phase I studies. E at 15mg QD plus oPac at 205 mg/m2 QD x 3 days every week is safe and has demonstrated efficacy in treating mBC. E is a , minimally absorbed, oral PGP inhibitor to prevent intestinal oPac efflux. The aims were to determine the safety and tolerability, recommended phase 2 dose (RP2D) of oPac/E in combination with Pem and to evaluate early clinical activity.