Journal article

A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia

Jason D Lickliter, Hui K Gan, Mark Voskoboynik, Surein Arulananda, Bo Gao, Adnan Nagrial, Peter Grimison, Michelle Harrison, Jianjun Zou, Lianshan Zhang, Stacey Luo, Michael Lahn, Howard Kallender, Andrea Mannucci, Catello Somma, Katherine Woods, Andreas Behren, Pablo Fernandez-Penas, Michael Millward, Tarek Meniawy

Drug Design, Development and Therapy | DOVE MEDICAL PRESS LTD | Published : 2020


Purpose: Camrelizumab inhibits PD-1 in non-clinical models and showed typical non-clinical pharmacokinetic (PK) and safety profiles for an IgG4 monoclonal antibody. We report results from the First-in-Human Phase 1 trial of camrelizumab in Australian population. Methods: Camrelizumab was administered to patients with advanced solid tumors who had failed standard therapies. In the dose-escalation phase (n=23), camrelizumab was administered intravenously at 1 mg/kg, 3 mg/kg, 6 mg/kg, and 10 mg/kg every 2 weeks. In dose expansion (n=26), camrelizumab was given at 200 mg or 600 mg every 4 weeks. Results: Two dose-limiting toxicities were observed during dose escalation: transaminase elevation an..

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