Dendreon has enrolled the first patient in a Phase I clinical trial of D3263 in patients with advanced cancer. D3263 is the company’s lead small molecule drug candidate designed to target TRPM8 in cancer cells and induce cell death.
The trial is an open-label, dose-escalation study evaluating the safety and pharmacokinetics of orally administered D3263 in patients with solid tumors that are refractory to standard therapies.
The Phase I trial will enroll three to six patients per cohort during the dose escalation phase of the study. An expansion cohort may be enrolled following determination of the maximum tolerated dose. The primary endpoint of the study will be safety, but patients also will be evaluated for antitumor activity as well as tolerance of the drug in order to determine the optimal schedule and level of dosing.
Mark Frohlich, chief medical officer of Dendreon, said: D3263 is a drug candidate that has potential applicability to multiple types of cancer as well as to benign prostatic hyperplasia. The ability of D3263 to inhibit growth of TRPM8 expressing tumors in preclinical studies coupled with its oral bioavailability make it an appealing product candidate to advance into human clinical trials.