Status:
RECRUITING
A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Mye...
Eligibility Criteria
Inclusion
- Voluntary and signed informed consent, good compliance.
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 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)
- According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated.
- Within 7 days before the first administration, the symptom score of myeloproliferative neoplasms should meet certain requirements.
- Patients with poor efficacy of JAK inhibitors (for phase Ib and phase II cohort 2, cohort 3)
- Patients who had not received JAK inhibitor treatment (for phase II cohort 1).
- Spleen enlargement.
- Peripheral blood primary cells and bone marrow primary cells were ≤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 (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotrophin (HCG) test is not negative within 7 days before the first administration and must be non-lactating patients.
Exclusion
- 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;
- Previous treatment with BET inhibitors combined with JAK inhibitor;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate withdrawal requirements for hydroxyurea, JAK inhibitors, androgen drugs, erythropoietin, long-acting recombinant interferon-α, etc.);
- Other malignancies within 3 years prior to first administration or currently present.
- Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) 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 and HCV RNA positive, 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 who have received Chinese patent medicines with anti-tumor indications specified in the approved drug package insert of China National Medical Products Administration (NMPA) within 2 weeks before the first administration;
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
- There was 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 (except JAK inhibitor-related clinical trials).
- According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06122831
Start Date
December 12 2023
End Date
April 1 2027
Last Update
December 8 2025
Active Locations (22)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 525000
2
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China, 530016
3
Cangzhou People's Hosipital
Cangzhou, Hebei, China, 061014
4
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China, 067020