The study is intended to evaluate CUDC-101 when administered concurrently with radiation and cisplatin in human papillomavirus negative (HPV-) locally advanced head and neck cancer patients.
The company expects to evaluate around 15-25 patients with human papillomavirus negative (HPV-) locally advanced head and neck cancer with CUDC-101.
The study aims to determine the tolerability, safety and maximum tolerated dose (MTD) of CUDC-101 in this patient population.
Curis president and CEO Dan Passeri said CUDC-101 has demonstrated clinical activity in head and neck cancer in Curis’ previous dose escalation and expansion studies.
"In addition, preclinical data suggests that HDAC inhibition, the third target of CUDC-101, can enhance the effects of both radiation and cisplatin therapy," Passeri said.