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news.Curis has announced that the first patient has been treated in a Phase I clinical trial of CUDC-101, a first-in-class small molecule drug candidate that has been designed as an inhibitor of epidermal growth factor receptor, epidermal growth factor receptor 2 and histone deacetylase.
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The Phase I trial is designed as an open-label dose escalation study of CUDC-101 in patients with advanced, refractory solid tumors. CUDC-101 will be administered on days one to five of a fourteen day cycle. The first patient enrolled in the Phase I study has completed five days of dosing.
The primary objectives of the Phase I trial are to evaluate the safety and tolerability of escalating doses of the Phase I molecule and to establish the maximum tolerated dose and dose limiting toxicities. Secondary objectives will be to assess the pharmacokinetics, efficacy and ability of CUDC-101 to inhibit HDAC, EGFR and Her2 in this patient population.
The study is expected to be conducted at two sites within the US and to enroll between 18 and 40 patients across several dose-escalating cohorts.
Dan Passeri, president and CEO of Curis, said: “We believe that CUDC-101’s combination of clinically-validated cancer targets in a single agent may represent an important advance in targeted cancer therapy with respect to efficacy and safety. Moreover, single multi-targeted agents may have potentially significant cost advantages over multiple drugs with the same target profile.”