A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF)

NCT06245941 | Terminated Phase 1

• 1 other identifier: TQ05105-TQB3909-Ib/II-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (3)

• Maximal tolerance dose (MTD)

  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)

  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

  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 Outcomes (12)

• Optimum effective rate

  Up to 120 weeks

• Onset time of splenic response

  Up to 120 weeks

• Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)

  Up to 120 weeks

• Percentage change in spleen volume from baseline

  Up to 60 weeks

• SVR35 at week 60

  Up to 60 weeks

Study Arms (2)

TQB3909 Tablets

EXPERIMENTAL

TQB3909 Tablets, orally administered. 28 days as a treatment cycle.

Drug: TQB3909 tablets

TQ05105 Tablets combined with TQB3909 Tablets

EXPERIMENTAL

TQ05105 Tablets combined with TQB3909 Tablets, orally administered. 28 days as a treatment cycle.

Drug: TQ05105 tablets; Drug: TQB3909 tablets

Interventions

TQ05105 tablets DRUG

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

TQ05105 Tablets combined with TQB3909 Tablets

TQB3909 tablets DRUG

TQB3909 is an inhibitor targeting B-cell lymphoma-2 (BCL-2) protein.

TQ05105 Tablets combined with TQB3909 Tablets; TQB3909 Tablets

Eligibility Criteria

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

You may qualify if:

• 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 Ib and phase II cohort 2)
• 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.

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;
• 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;

Sponsors & Collaborators

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

Study Sites (5)

The Second People's Hospital of Hefei

Hefei, Anhui, 230012, China

Location

Hennan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Xijing Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

People's Hospital of Tianjin

Tianjin, Tianjin Municipality, 300122, China

Location

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310003, China

Location

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: May 13, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-07

Locations

CN (5)