Cantuzumabmertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study. To determine the maximum tolerated dose and pharmacokinetics of cantuzumabmertansine, an immunoconjugate of the potent maytansine derivative (DM1) and the humanized monoclonal antibody (huC242) directed to CanAg, intravenously (i.v.) once every 3 weeks and to seek evidence of antitumor activity. Patients with CanAg-expressing solid malignancies were treated with escalating doses of cantuzumabmertansine administered i.v. every 3 weeks. The pharmacokinetic parameters of cantuzumabmertansine, the presence of plasma-shed CanAg, and the development of both human antihuman and human anti-DM1 conjugate antibodies also were characterized. Thirty-seven patients
A phase I study of cantuzumabmertansine administered as a single intravenous infusion once weekly in patients with advanced solid tumors. The purpose is to determine the maximum-tolerated dose, assess the toxicities, characterize the pharmacokinetic behavior, and seek preliminary evidence of biological activity of cantuzumabmertansine when administered as a weekly i.v. infusion without interruption. Patients with incurable solid tumors that expressed the target antigen for cantuzumabmertansine, CanAg, were treated with doses of cantuzumabmertansine ranging from 40 to 138 mg/m(2). The maximum-tolerated dose was defined as the highest dose at which no more than 1 of 6 patients experienced dose-limiting toxicity. Plasma concentrations of cantuzumabmertansine and total humanized antibody