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

NCT06186804 | Enrolling By Invitation Phase 2

• 1 other identifier: ABSK021-201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

cGvHD

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Adverse Events

  Through study completion, an average of 2 years

Study Arms (1)

ABSK021

EXPERIMENTAL

Patients will be instructed to take a specified dose of ABSK021 at the same time each day.

Drug: ABSK021

Interventions

ABSK021 DRUG

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.

ABSK021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent and agree to comply with the requirements and restrictions set out in the informed consent.
• At the time of signing the informed consent., the patient must be at least 18 years old, regardless of gender ；
• Allogeneic hematopoietic stem cell transplantation from any donor source using bone marrow, peripheral blood stem cells, or cord blood.
• Patients who have received at least 1 line of systemic therapy
• 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.
• 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.
• \. 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

You may not qualify if:

• In previous treatment, he received highly selective colony stimulating factor 1 receptor (CSF-1R) targeted therapy, including small molecule or large molecule drugs;
• A known history of allergy to components of the investigational drug composition ;
• Patients continued to use CYP3A4 in combination with antifungal agents or in the two weeks prior to the initial administration of ABSK021 Strong inducer;
• The patient has received more than 5 lines of systemic therapy for cGvHD;
• The patient presented with aGvHD symptoms without cGvHD symptoms ;
• Any evidence of potential tumor or recurrence of post-transplant lymphoproliferative disease at the screening stage .
• There are factors that have been determined by the investigators to have a significant influence on oral drug absorption
• Present with cholestatic disease, or unresolved hepatic sinus obstruction syndrome/venous obstructive disease;
• active infection.
• 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;
• Prior treatment (adverse events did not return to ≤ Grade 2 (CTCAE v5.0);
• Pregnant or lactating women;
• Patients who are unable to or disagree with contraception.

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (14)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

The Second Affiliated Hospital of the Army Medical University

Chongqing, Chongqing Municipality, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Guangdong Provincial Peoplep's Hospital

Guangzhou, Guangdong, China

Location

ZhuJiang Hospital of Southern Medical University

Zhujiang, Guangdong, China

Location

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

Wuhan, Hubei, China

Location

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

Wuhan, Hubei, China

Location

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

Hangzhou, Jiangsu, China

Location

The First affiliated hospital of SuZhou University

Suzhou, Jiangsu, 215000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Location

The First Teaching Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be instructed to take a specified dose of ABSK021 at the same time each day. In Cycle 1, the patient should take one dose every morning after waking up; After the 15th day of the 1st cycle, the specified dose may be taken in the morning or evening, but should be taken at the same time every day.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 2, 2024
• Study Start: May 30, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 12, 2024

Record last verified: 2023-10

Locations

CN (14)