The trial will be an open-label, Phase II study of IT-101 intended to demonstrate safety and efficacy in patients with relapsed or refractory lymphoma, and will be preceded by a brief dose finding run-in phase. Patients with relapsed or refractory lymphoma, including B-cell, T-cell, and Hodgkin lymphoma who satisfy eligibility requirements will be considered for admission to the trial.
IT-101, a drug conjugate of camptothecin and Calando’s proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and unique pharmacokinetic characteristics, the company said.
Stephen Forman, lead investigator of the study, said: “This is a very important and exciting trial to determine the efficacy and tolerability of a rationally designed and novel nanotechnology based drug delivery system of a cancer chemotherapeutic drug, with impressive preclinical activity in lymphoma.”