US drug developer CuraGen has met the criteria to proceed to the next stage of its Phase II trial of CR011-vcMMAE, a treatment for melanoma.
The ongoing open-label, multicenter, study is evaluating the antibody-drug conjugate in the treatment of patients with unreselectable Stage III or Stage IV melanoma, utilizing the Simon 2-Stage design. The candidate has met the efficacy criteria for the first stage, with one of the six subjects expressing a comfirmed objective response.
The trial will now advance to a second stage, expanding to include 32 patients. Results of an earlier, Phase I trial were reported at the American Society of Clinical Oncology in Chicago earlier this month.
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