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Clinical Trial Summary

The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.


Clinical Trial Description

Part I: PK/PD and safety evaluation -Two regimens of ICP-022 (High dose QD and low dose BID) were designed for assessment of safety, as well as PK/PD profiles. The recommended dose of phase II clinical study will be determined according to the Part I results. Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R MCL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03494179
Study type Interventional
Source Beijing InnoCare Pharma Tech Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date April 2, 2018
Completion date December 31, 2023

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