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First-in-human phase I, dose-escalation and -expansion study of telisotuzumab vedotin, an antibody–drug conjugate targeting c-Met, in patients with advanced solid tumors

Journal of Clinical Oncology Oct 10, 2018

Strickler JH, et al. - Telisotuzumab vedotin (Teliso-V), formerly called ABBV-399, an antibody–drug conjugate of the anti–c-Met monoclonal antibody ABT-700 and monomethyl auristatin E, was tested in this first-in-human study, with a focus on its safety, tolerability, pharmacokinetics, and maximum tolerated dose. The study included eight cohorts in which 3-6 patients with advanced solid tumors were enrolled for dose escalation (0.15 to 3.3 mg/kg). Patients with non–small-cell lung cancer with c-Met–overexpressing tumors (c-Met positive; immunohistochemistry membrane H-score ≥ 150) were enrolled in the dose-expansion phase. Researchers administered Teliso-V monotherapy intravenously on day 1 once every 3 weeks. They observed favorable safety and tolerability profiles with Teliso-V monotherapy in addition to antitumor activity.

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