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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186804
• Other study ID #: ABSK021-201
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: October 2023
• Source: Abbisko Therapeutics Co, Ltd
• Contact: Yuan LU, doctor
• Phone: 13700000000
• Email: clinical[@]abbisko.cn
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 30, 2026
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sign the informed consent and agree to comply with the requirements and restrictions set out in the informed consent.

2. At the time of signing the informed consent., the patient must be at least 18 years old, regardless of gender ;

3. Allogeneic hematopoietic stem cell transplantation from any donor source using bone marrow, peripheral blood stem cells, or cord blood.

4. Patients who have received at least 1 line of systemic therapy

5. If the patient is being treated with glucocorticoids or calcineurin inhibitor(CNI), the patient should have received a stable dose of the above treatment for not less than 2 weeks prior to the first use of ABSK021.

6. ECOG (Eastern Cooperative Oncology Group Performance Status) physical strength score 0-2;7. The patient had sufficient organ and bone marrow function within 14 days prior to the first use of ABSK021.

8. For patients with Part A only: antifungal drugs that are currently being used in combination with CYP3A4 potent inhibitors should have been continuously used in accordance with regulations for no less than one week before the first use of ABSK021

Exclusion Criteria:

1. In previous treatment, he received highly selective colony stimulating factor 1 receptor (CSF-1R) targeted therapy, including small molecule or large molecule drugs;

2. A known history of allergy to components of the investigational drug composition ;

3. Patients continued to use CYP3A4 in combination with antifungal agents or in the two weeks prior to the initial administration of ABSK021 Strong inducer;

4. The patient has received more than 5 lines of systemic therapy for cGvHD;

5. The patient presented with aGvHD symptoms without cGvHD symptoms ;

6. Any evidence of potential tumor or recurrence of post-transplant lymphoproliferative disease at the screening stage .

7. There are factors that have been determined by the investigators to have a significant influence on oral drug absorption

8. Present with cholestatic disease, or unresolved hepatic sinus obstruction syndrome/venous obstructive disease;

9. active infection.

10. During the screening period, the investigators judged that the patients had insufficient pulmonary function reserve, with FEV1= 39% or pulmonary function classification score of 3;

11. Prior treatment (adverse events did not return to = Grade 2 (CTCAE v5.0);

12. Pregnant or lactating women;

13. Patients who are unable to or disagree with contraception.

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• cGvHD
• Graft vs Host Disease

Intervention

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

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Second Affiliated Hospital of the Army Medical University	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong Provincial Peoplep's Hospital	Guangzhou	Guangdong
China	The Fir St Affiliated Hospital,Zhejiang Univer Sity School of Medicine	Hangzhou	Jiangsu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First affiliated hospital of SuZhou University	Suzhou	Jiangsu
China	Hematology Hospital of Chinese Academy of Medical Sciences	Tianjin	Tianjin
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 First Teaching Hospital of Xinjiang Medical University	Xinjiang	Xinjiang
China	ZhuJiang Hospital of Southern Medical University	Zhujiang	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Abbisko Therapeutics Co, Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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);	Starting from the first medication, observe for 31 days
Primary	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	6 months
Secondary	Adverse Events	Safety assessments will be carried out during the trial.	Through study completion, an average of 2 years