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Clinical Trial Summary

This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.


Clinical Trial Description

This is a phase II, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of ABSK021 in patients with hormone refractory or relapsed cGvHD. This study consisted of Part A and Part B, all cGvHD patients in this study will receive continuous oral treatment with ABSK021 once a day (QD) in a 28-day cycle, complete the core treatment period and extended treatment period, and receive regular follow-up until the termination of treatment is determined. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06186804
Study type Interventional
Source Abbisko Therapeutics Co, Ltd
Contact Yuan LU, doctor
Phone 13700000000
Email clinical@abbisko.cn
Status Recruiting
Phase Phase 2
Start date May 30, 2023
Completion date December 30, 2026

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