CuraGen’s phase I/II trial, evaluating CR011-vcMMAE for the treatment of advanced breast cancer, has met the efficacy criteria for advancement to the second stage of enrollment.
CR011-vcMMAE is an antibody-drug conjugate (ADC) that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE).
CR011-vcMMAE is currently in two phase-II trials assessing its safety and efficacy in the treatment of melanoma and metastatic breast cancer.
So far, 29 patients have been enrolled in the trial, including 15 in the phase-II portion. Two of the first four evaluable phase-II patients were progression-free at 12 weeks, therefore, as part of the Simon 2-Stage design, the phase-II trial will now advance to the second stage, said the company.