TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients

NCT ID: NCT06388759

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-08-12

Brief Summary

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis.

Conditions

Myelofibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQ05105 Tablets

TQ05105 Tablets，28 days as a treatment cycle.

Group Type: EXPERIMENTAL

TQ05105 Tablets

Intervention Type: DRUG

TQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 （JAK2） Inhibitor

Interventions

TQ05105 Tablets

TQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 （JAK2） Inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects voluntarily participated in this study, signed informed consent forms, and demonstrated good compliance；
• Age: 18 or older (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;
• Patients with poor efficacy or intolerant of Ruxolitinib;
• 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 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;
• Previous treatment with JAK inhibitors(except ruxolitinib);
• 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 (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs;
• The non-hematological toxicity caused by previous treatment did not return to grade≤1;
• 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;
• Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia, QT interval prolongation and ≥ grade 2 congestive heart failure;
• 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;
• Use of any MF medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to first administration;
• 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;
• According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Union Hospital Tongji College Huazhong University of Science And Technology

Wuhan, Hubei, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Hong M, Ding D, Zhang M, Gao S, Song L, Wu D, Lao S, Yu D, Chang C. A first-in-class JAK/ROCK inhibitor, Rovadicitinib in patients with myelofibrosis who were refractory or relapsed or intolerant to Ruxolitinib: A single-arm, multicenter, open-label, phase Ib study. Eur J Pharmacol. 2025 Oct 15;1005:178032. doi: 10.1016/j.ejphar.2025.178032. Epub 2025 Aug 5.

Reference Type: DERIVED

PMID: 40752760 (View on PubMed)

Other Identifiers

TQ05105-Ib-03

Identifier Type: -

Identifier Source: org_study_id