The uniquely designed Phase I dose-escalation study in adult patients with advanced cancer will investigate the safety and preliminary efficacy of CNDO101 (5-imino-13 deoxy-doxorubicin). The trial has eight dose levels and allows patients to move to higher doses with each cycle if there is no evidence of toxicity. This modified design should allow the investigators to demonstrate evidence of anti-cancer activity. Coronado expects to enroll at least 30 patients in this study.
RJ Tesi, president and CEO of Coronado Biosciences, said “CNDO101 is a new drug that has been rationally designed to eliminate cardiotoxicity and improve tolerability so that it can potentially be used in combination with taxanes and other therapeutic agents to provide patients with improved treatment options.”