First-time-in-Man EGFR targeted minicells

To examine the safety of the minicell delivery system, a first-time-in-human, open-label, phase I clinical study epidermal growth factor receptor (EGFR)-targeted, paclitaxel-loaded minicells (EGFR-minicells-Pac) was conducted in patients with advanced solid tumors. Patients received 5 weekly infusions followed by a treatment free week. Seven dose levels were evaluated using a 3+3 dose-escalation design. Primary objectives were safety, tolerability and determination of the maximum tolerated dose. Secondary objectives were assessment of immune/inflammatory responses and antitumor activity.