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news.Synta Pharmaceuticals, a biopharmaceutical company, has announced that the first patient has been treated in a single agent, dose escalation clinical study of its novel oxidative stress inducer, elesclomol, in solid tumors.
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The open-label, dose-escalation study of elesclomol in up to 30 subjects with advanced metastatic or unresectable solid tumors is designed to identify the maximum tolerated dose of elesclomol sodium based on a weekly infusion dosing schedule. Pharmacokinetic, safety and efficacy endpoints, including tumor response and durability of response will also be evaluated.
According to the company, this study uses a water soluble formulation, allowing flexible administration, either as monotherapy or in combination with other anticancer agents. Elesclomol is not approved for marketing by any regulatory body in any country.
Elesclomol is also being studied in an open-label Phase I/II study of elesclomol in combination with docetaxel in approximately 34 patients with advanced metastatic, hormone refractory prostate cancer. Additional trials to evaluate elesclomol as a therapy for other cancers are planned.
Eric Jacobson, senior vice president and chief medical officer of Synta, said: This is the first clinical trial that will study the potential anticancer activity of elesclomol as a single agent. In addition, this trial will allow us to further evaluate the safety and tolerability of elesclomol in solid tumors.