The primary objective of the Phase Ib dose-escalation trial is to determine the safety and tolerability of a 72-hour continuous infusion of PX-12 given on the first three days of a 21-day cycle.
Other objectives of the trial include an evaluation of the pharmacokinetics and pharmacodynamics of the prolonged infusion, together with identification of any anti-tumor activity. The trial is expected to enroll up to 28 patients at three centers in the US.
PX-12 is a proprietary small molecule inhibitor of thioredoxin, a protein that regulates diverse molecular pathways that contribute to the growth, survival and drug resistance of many cancers.