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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of the Army Medical University
Chongqing, Chongqing Municipality, China
Dose limited toxicity (DLT) at each dose can assess the incidence of DLT in patients during the observation period of DLT (Part A only)
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT);
Time frame: Starting from the first medication, observe for 31 days
Overall response rate after 6 cycles of treatment
Proportion of participants with CR or PR after 6 cycles of treatment as defined by the 2014 NIH Consensus Development Project on Criteria in cGVHD
Time frame: 6 months
Adverse Events
Safety assessments will be carried out during the trial.
Time frame: Through study completion, an average of 2 years
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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
...and 4 more locations