One patient each in the 3.0-mg/kg (n = 9) and 3.3-mg/kg (n = 3) cohorts experienced dose-limiting toxicities. ResultsForty-eight patients were enrolled (median age, 65 years 35.4% NSCLC median four prior therapies). Safety, tolerability, pharmacokinetics, and maximum tolerated dose were determined. Patients received Teliso-V monotherapy intravenously on day 1 once every 3 weeks. The dose-expansion phase enrolled patients with non-small-cell lung cancer (NSCLC) with c-Met-overexpressing tumors (c-Met positive immunohistochemistry membrane H-score ≥ 150). Materials and methodsFor dose escalation, three to six patients with advanced solid tumors were enrolled in eight cohorts (0.15 to 3.3 mg/kg). PurposeThis first-in-human study evaluated 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.
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