Solid Tumor Clinical Trial
Official title:
Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.
This study consists of phase Ia and Ib portions for patients with solid tumors.
Phase Ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and
1.0mg/kg of Mogamulizumab.
Phase Ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of
Mogamulizumab based on the phase Ia portion to pursue safer and immunologically more
efficient dose.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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