cGvHDPhase 2NCT06186804
A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)
A Phase 2 study testing ABSK021 in people with cGvHD, run by Abbisko Therapeutics Co, Ltd at 14 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cGvHD
- What is being tested?
- ABSK021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 14 sitesChina
- Study dates
- 30 May 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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 .
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites
Peking University People's Hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
West China Hospital of Sichuan University
Chengdu, Sichuan
The Second Affiliated Hospital of the Army Medical University
Chongqing, Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou, Fujian
Guangdong Provincial Peoplep's Hospital
Guangzhou, Guangdong
The Fir St Affiliated Hospital,Zhejiang Univer Sity School of Medicine
Hangzhou, Jiangsu
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The First affiliated hospital of SuZhou University
Suzhou, Jiangsu, 215000
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei
The First Teaching Hospital of Xinjiang Medical University
Xinjiang, Xinjiang
ZhuJiang Hospital of Southern Medical University
Zhujiang, Guangdong
About this study
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
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.
Read the detailed 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.
- Conditions
- cGvHD
- Being tested
- ABSK021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK021Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ABSK021 | Experimental | Patients will be instructed to take a specified dose of ABSK021 at the same time each day. Receives: Drug: ABSK021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: 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
Measured: 6 months
Secondary outcomes (1)
Adverse Events
Safety assessments will be carried out during the trial.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start30 May 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGvHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186804
- Sponsor's protocol ID
- ABSK021-201
- Status last verified
- Oct 2023
- First submitted
- 28 Nov 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06186804
- Acronym / sponsor ID
- ABSK021-201
- Conditions
- cGvHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ABSK021 | Experimental | Drug: ABSK021Patients will be instructed to take a specified dose of ABSK021 at the same time each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK021Patients 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. | Drug | ABSK021 |
Primary outcome
Dose limited toxicity (DLT) at each dose can assess the incidence of DLT in patients during the observation period of DLT (Part A only)
Time frame: Starting from the first medication, observe for 31 days
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT);
Overall response rate after 6 cycles of treatment
Time frame: 6 months
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
1 secondary outcome
Adverse Events
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABSK021 in people with cGvHD, run by Abbisko Therapeutics Co, Ltd at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) at each dose can assess the incidence of DLT in patients during the observation period of DLT (Part A only) (time frame: Starting from the first medication, observe for 31 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.