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

Last updated: August 8, 2024
Sponsor: Abbisko Therapeutics Co, Ltd
Overall Status: Active - Enrolling

Phase

2

Condition

N/A

Treatment

ABSK021

Clinical Study ID

NCT06186804
ABSK021-201
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  3. Allogeneic hematopoietic stem cell transplantation from any donor source using bonemarrow, 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 lessthan 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 daysprior to the first use of ABSK021.

  7. For patients with Part A only: antifungal drugs that are currently being used incombination with CYP3A4 potent inhibitors should have been continuously used inaccordance with regulations for no less than one week before the first use ofABSK021

Exclusion

Exclusion Criteria:

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

  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 twoweeks 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 lymphoproliferativedisease at the screening stage .

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

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

  9. active infection.

  10. During the screening period, the investigators judged that the patients hadinsufficient pulmonary function reserve, with FEV1≤ 39% or pulmonary functionclassification 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.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: ABSK021
Phase: 2
Study Start date:
May 30, 2023
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • The Second Affiliated Hospital of the Army Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Guangdong Provincial Peoplep's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • ZhuJiang Hospital of Southern Medical University

    Zhujiang, Guangdong
    China

    Site Not Available

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

    Wuhan, Hubei
    China

    Site Not Available

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

    Wuhan, Hubei
    China

    Site Not Available

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

    Hangzhou, Jiangsu
    China

    Site Not Available

  • The First affiliated hospital of SuZhou University

    Suzhou, Jiangsu 215000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin
    China

    Site Not Available

  • The First Teaching Hospital of Xinjiang Medical University

    Xinjiang, Xinjiang
    China

    Site Not Available

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