Curis has treated the first patient in a Phase I combination trial of CUDC-101, a first-in-class treatment that simultaneously inhibits histone deacetylase (HDAC), Histone Deacetylase 6 drugs development Market and epidermal growth factor receptor (EGFR).

The purpose of the Phase I combination trial, which is open-label and dose-escalating, is to test CUDC-101 in approximately 15 to 25 patients with locally advanced head and neck cancer who are HPV-negative.

The study's primary objective is to determine the drug candidate's safety, tolerability, and maximum tolerated dose (MTD).

The pharmacokinetics of CUDC-101, the tumor markers for response associated with CUDC-101, cisplatin, and radiation activity, and the evaluation of the combination of CUDC-101, cisplatin, and radiation therapy are the secondary objectives.

CUDC-101 has been shown to be effective in patients with head and neck cancer in dose expansion and dose escalation studies previously conducted.

In order to determine whether the addition of CUDC-101 can improve the efficacy and durability of cisplatin and radiation therapy in this patient population, the company plans to conduct a randomised Phase II two-arm clinical trial in which head and neck cancer patients will receive either cisplatin and radiation plus or minus CUDC-101.

In addition to enrolling 45 of 50 patients in an ongoing Phase I expansion trial to test CUDC-101 in patients with specific tumor types, such as breast, gastric, head and neck, liver, and non-small cell lung cancers, Curis has completed a Phase I dose escalation clinical trial of CUDC-101 in 25 patients with advanced, refractory solid tumors.