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First-in-human, multicenter, phase I dose-escalation and expansion study of anti-mesothelin antibody–drug conjugate anetumab ravtansine in advanced or metastatic solid tumors

Journal of Clinical Oncology Jun 03, 2020

Hassan R, Blumenschein GR, Moore KN, et al. - Researchers undertook this phase I study, which represents the first-in-human study of this kind, wherein anetumab ravtansine (an antibody–drug conjugate of anti-mesothelin antibody linked to maytansinoid DM4) was tested for its safety, tolerability, pharmacokinetics, and clinical activity among patients suffering from advanced, metastatic, or recurrent solid tumors known to express the tumor-differentiation antigen mesothelin. This study included 148 adult patients with multiple solid tumor types. Experts administered anetumab ravtansine once every 3 weeks in 10 dose-escalation cohorts including patients suffering from advanced or metastatic solid tumors (0.15-7.5 mg/kg), and 6 expansion cohorts of patients with advanced, recurrent ovarian cancer or malignant mesothelioma were given anetumab ravtansine at the maximum tolerated dose once every 3 weeks, 1.8 mg/kg once per week, and 2.2 mg/kg once per week. Findings revealed a manageable safety and favorable pharmacokinetic profile as well as encouraging preliminary antitumor activity of anetumab ravtansine in heavily pretreated patients with mesothelin-expressing solid tumors. The findings permitted for the ascertainment of advised doses, schedules, and patient populations for anetumab ravtansine in phase II investigations.

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