Curis has treated the first patient at the University of Colorado Cancer Center in a Phase I combination trial of CUDC-101, a first-in-class therapeutic to simultaneously inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC).
The open-label, dose escalation Phase I combination trial is designed to test CUDC-101 when administered concurrently with radiation and cisplatin in approximately 15-25 human papillomavirus negative (HPV-) locally advanced head and neck cancer patients.
The primary objective of the study is to establish the safety, tolerability and maximum tolerated dose (MTD) of the drug candidate.
Secondary objectives are to evaluate the efficacy of CUDC-101, cisplatin and radiation therapy combination, assess the pharmacokinetics of CUDC-101 and evaluate tumor markers for response associated with CUDC-101, cisplatin and radiation activity.
In the previous dose escalation and expansion studies, CUDC-101 has demonstrated clinical activity in head and neck cancer.
The company is planning to conduct a randomised Phase II two-arm clinical trial in which head and neck cancer patients will receive cisplatin and radiation plus or minus CUDC-101, to evaluate whether the addition of CUDC-101 can improve the efficacy and durability of cisplatin and radiation therapy in this patient population.
Curis has completed a Phase I dose escalation clinical trial of CUDC-101 in 25 patients with advanced, refractory solid tumors and has also enrolled 45 of 50 patients in an ongoing Phase I expansion trial to test CUDC-101 in patients with specific tumor types, including breast, gastric, head and neck, liver and non-small cell lung cancers.