"We are excited to investigate CUDC-427 monotherapy using a continuous daily dosing regimen, which we believe has the potential to further enhance its anti-tumor activity as a single agent in difficult to treat cancers," said Ali Fattaey, Curis President and Chief Operating Officer. "Additionally, the expansion phase of this trial will further study CUDC-427's activity in patients with ovarian and fallopian tube cancers, where we expect to investigate CUDC-427 in patients with cancers of different genetic profiles, including patients with known gene mutations."
In addition to this Phase 1 trial, Curis is also planning to initiate clinical studies with CUDC-427 in patients with breast cancer and other malignancies. Curis is currently planning to initiate a clinical study evaluating the use of CUDC-427 in combination with capecitabine to treat HER2-negative breast cancer patients in 2013. The trial will be designed to initially determine the optimal dose of CUDC-427 in combination with the standard capecitabine regimen. In addition, the company also plans to examine CUDC-427 for the treatment of aggressive lymphomas as well as certain indolent lymphomas such as MALT lymphomas.
About the Phase 1 Dose Escalation Trial
This Phase 1, open-label, multicenter study is designed to determine the MTD and recommended Phase 2 dose of oral CUDC-427 administered as a single agent twice-daily on a continuous daily schedule for a 21-day cycle in patients with advanced and refractory solid tumors or lymphomas. The secondary objectives of the study are to assess CUDC-427's safety and tolerability, pharmacokinetics, exploratory biomarkers of activity and preliminary anti-cancer activity. Patients will be dose escalated according to the standard 3+3 design with a starting dose of 400 mg/day (200 mg BID) and escalated at increments of 200 mg/day. Upon determination of MTD or the recommended Phase 2 dose, the trial is designed to enroll up to an additional 12 patients in the expansion cohort of a particular cancer type, primarily ovarian and fallopian tube cancers.