A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)

cGvHD Clinical Trial

Official title: A Multicenter, Single-arm, Open-label, Phase II Clinical Study. This Study Consisting of Part A and Part B to Evaluate the Efficacy and Safety of ABSK021 (Pimicotinib) in Patients With Chronic Graft Versus Host Disease

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• cGvHD
• Graft vs Host Disease

• 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