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

NCT06388759 | Terminated Phase 1

• 1 other identifier: TQ05105-Ib-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Spleen volume reduction (SVR35)≥35% from baseline

  The proportion of subjects with spleen volume reduction ≥35%from baseline at the end of treatment at week 24.

  up to 24 weeks

Secondary Outcomes (10)

• Optimum effective rate

  up to 120 weeks

• Onset time of splenic response

  up to 120 weeks

• Duration of maintenance of spleen response (DoMSR) ≥35% reduction

  up to 120 weeks

• Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline

  up to 24 weeks

• The total symptom score of MPN-SAF TSS decreased compared with baseline

  up to 120 weeks

Study Arms (1)

TQ05105 Tablets

EXPERIMENTAL

TQ05105 Tablets，28 days as a treatment cycle.

Drug: TQ05105 Tablets

Interventions

TQ05105 Tablets DRUG

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

TQ05105 Tablets

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (6)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Union Hospital Tongji College Huazhong University of Science And Technology

Wuhan, Hubei, 430071, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (1)

• 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.

  PMID: 40752760 DERIVED

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: August 1, 2022
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (6)