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ENROLLING BY INVITATION
NCT06186804
PHASE2

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

Sponsor: Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2023-05-30

Completion Date

2026-12-30

Last Updated

2024-08-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

ABSK021

Patients in each phase and dose group will receive continuous treatment with oral administration once a day for 28 days/cycle until conditions for treatment termination are met.

Locations (14)

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of the Army Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Provincial Peoplep's Hospital

Guangzhou, Guangdong, China

ZhuJiang Hospital of Southern Medical University

Zhujiang, Guangdong, China

Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

The Fir St Affiliated Hospital,Zhejiang Univer Sity School of Medicine

Hangzhou, Jiangsu, China

The First affiliated hospital of SuZhou University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Teaching Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China