Elesclomol is a first-in-class investigational drug candidate that triggers programmed cell death in cancer cells by targeting mitochondrial energy production in cancer cells.
The trial, which will enroll up to 36 patients with relapsed or refractory AML, is being conducted at Princess Margaret Hospital in Toronto, Canada and at Memorial Sloan-Kettering Cancer Center in New York.
In the study, patients will receive elesclomol sodium once weekly at a starting dose of 200 mg/m2, with dose escalation planned based on safety and tolerability.
The primary endpoints are to characterise the safety and tolerability of elesclomol sodium and establish the pharmacokinetics of elesclomol and its metabolites in this patient population.
Secondary endpoints include evaluating the activity of elesclomol as a monotherapy in the treatment of AML.