- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06245941
A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF)
January 30, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Moderate- and High-risk Myelofibrosis
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 tablets combined with TQB3909 tablets in patients with moderate- and high-risk Myelofibrosis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
93
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hong yan Tong, Doctor
- Phone Number: 13958122357
- Email: tonghongyan@zju.edu.cn
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Hennan Cancer Hospital
-
Contact:
- Hu Zhou, Doctor
- Phone Number: 13939068863
- Email: papertigerhu@163.com
-
-
Shaanxi
-
Xian, Shaanxi, China, 710032
- Xijing Hospital of the Fourth Military Medical University
-
Contact:
- Guang xun Gao, Doctor
- Phone Number: 13991907320
- Email: gaoguangxun@fmmu.edu.cn
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-
Tianjin
-
Tianjin, Tianjin, China, 300122
- People's Hospital of Tianjin
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Contact:
- Xing li Zhao, Doctor
- Phone Number: 13752255454
- Email: tjsrmyyxyk@163.com
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-
Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Voluntarily participate in the study and signed informed consent with good compliance;
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2; Life expectancy ≥ 24 weeks;
- Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV-MF), or post essential thrombocythemia myelofibrosis (post-ET-MF);
- Those with moderate or high risk myelofibrosis evaluated according to Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria, or those with high risk myelofibrosis according to National Comprehensive Cancer Network (NCCN) guidelines prognostic grading criteria;
- Patients with poor efficacy of JAK inhibitors (for monotherapy of TQB3909, phase Ib and phase II cohort 2);
- Patients who had not received JAK inhibitor treatment (for phase II cohort 1)
- Spleen enlargement;
- Peripheral blood primary cells and bone marrow primary cells are ≤10%;
- No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration
- The Main organ function is normal;
- Men and women of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study.
Exclusion Criteria:
- Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
- Patients who have previously received BCL-2 inhibitor combined with JAK inhibitor therapy;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- Other malignancies within 3 years prior to first administration or currently present.
- Patients with multiple factors affecting oral or absorption of drugs;
- Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
- Presence of congenital bleeding disorder and congenital coagulopathy;
- Patients who had arterial/venous thrombosis events within 6 months before the first administration.
- Have a history of mental drug abuse, or have a mental disorder.
- Active or uncontrolled severe infection;
- Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection , or active Corona Virus Disease 2019 (COVID-19) infection;
- Patients with grade III or above congestive heart failure, unstable angina pectoris or myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation within 6 months before the first administration;
- Unsatisfactory blood pressure control despite standard therapy;
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
- Patients with a history of immunodeficiency disease or organ transplantation;
- Patients with epilepsy requiring treatment;
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
- There is a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period.
- People with known hypersensitivity to the study drug and excipients;
- Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
- Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration
- Any MF treatment drugs, any immunomodulators, or any immunosuppressants were used within 2 weeks prior to the first dose
- According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQB3909 Tablets
TQB3909 Tablets, orally administered.
28 days as a treatment cycle.
|
TQB3909 is an inhibitor targeting B-cell lymphoma-2 (BCL-2) protein.
|
Experimental: TQ05105 Tablets combined with TQB3909 Tablets
TQ05105 Tablets combined with TQB3909 Tablets, orally administered.
28 days as a treatment cycle.
|
TQB3909 is an inhibitor targeting B-cell lymphoma-2 (BCL-2) protein.
TQ05105 is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal tolerance dose (MTD)
Time Frame: Up to 2 years.
|
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered as MTD.
|
Up to 2 years.
|
Recommended phase II dose (RP2D)
Time Frame: Up to 2 years
|
The RP2D is defined as the lower dose level to MTD based on the safety profile
|
Up to 2 years
|
35% reduction in spleen volume (SVR35) at week 24
Time Frame: Up to 24 weeks
|
The proportion of subjects with a ≥35% reduction in spleen volume from baseline at the end of treatment at week 24
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)
Time Frame: Up to 120 weeks
|
The time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction is < 35% from baseline.
|
Up to 120 weeks
|
Progression-free survival (PFS)
Time Frame: Up to 120 weeks
|
The time interval from the first dose to the date of the occurrence of any of the following events, whichever occurs first:(1) Spleen volume increased by ≥25% compared with the screening period ; (2) Death caused by any cause.
|
Up to 120 weeks
|
Leukemia free survival (LFS)
Time Frame: Up to 120 weeks
|
The time interval from the date of the first dose to the date of any of the following events, whichever occurs first: (1) the date of the first bone marrow smear showing the original cell ≥20% ;(2) The first peripheral blood smear showed that the original cells ≥ 20% and the absolute value of the original cells ≥1×10^9/L and lasted for at least 2 weeks; (3) Death caused by any reason.
|
Up to 120 weeks
|
Incidence of adverse events (AEs)
Time Frame: Baseline up to 120 weeks
|
Incidence rate of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
|
Baseline up to 120 weeks
|
Severity of adverse events (AEs)
Time Frame: Baseline up to 120 weeks
|
Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
|
Baseline up to 120 weeks
|
Optimum effective rate
Time Frame: Up to 120 weeks
|
The proportion of subjects with at least once spleen volume reduction ≥ 35% from baseline
|
Up to 120 weeks
|
Onset time of splenic response
Time Frame: Up to 120 weeks
|
The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from baseline
|
Up to 120 weeks
|
Percentage change in spleen volume from baseline
Time Frame: Up to 60 weeks
|
Percentage change in spleen volume of subjects from baseline after treatment.
|
Up to 60 weeks
|
SVR35 at week 60
Time Frame: Up to 60 weeks
|
The proportion of subjects with a ≥35% reduction in spleen volume compared to baseline after treatment at week 60.
|
Up to 60 weeks
|
Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF-TSS)
Time Frame: Up to 60 weeks
|
The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% from baseline.
MPN-SAF-TSS is a tool for evaluating the disease burden of patients with myeloproliferative neoplasms.
Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score.
The higher the score, the more severe the symptoms are.
|
Up to 60 weeks
|
MPN-SAF-TSS decrease
Time Frame: Up to 60 weeks
|
The time and duration when the MPN-SAF-TSS decreased by ≥50% compared to baseline for the first time.
|
Up to 60 weeks
|
Overall Survival (OS)
Time Frame: Up to 120 weeks
|
The time from the first time the subject received treatment to death due to any cause
|
Up to 120 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
January 30, 2024
First Posted (Actual)
February 7, 2024
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQ05105-TQB3909-Ib/II-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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