The open-label, multi-center, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of the antibody, CR011-vcMMAE, for patients with unresectable stage III or stage IV melanoma who have failed no more than one prior line of cytotoxic therapy. CuraGen anticipates preliminary results from this phase I trial will be available in the fourth quarter of 2007.
The first part of the trial will evaluate cohorts of patients receiving increasing doses of the antibody to determine the maximum tolerated dose (MTD). After determination of the MTD, up to approximately 30 additional patients will be enrolled and treated at the MTD to further define safety and efficacy in this phase I trial.
“We believe the disease specificity and targeted nature of CR011-vcMMAE will accelerate the evaluation of this therapeutic in the clinic, where we hope to replicate the activity we saw with this agent in preclinical studies,” stated Dr Frank Armstrong, president and CEO of CuraGen.