A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)

NCT06122831 | Recruiting Phase 1

• 1 other identifier: TQ05105-TQB3617-Ib/II-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 22

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 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 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)

  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 (14)

• SVR35

  Up to 120 weeks

• 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

• Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)

  Up to 60 weeks

Study Arms (1)

TQ05105 Tablets + TQB3617 Capsules

EXPERIMENTAL

TQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle. TQB3617 Capsules, orally administered, 21 days as a treatment cycle.

Drug: TQ05105 Tablets; Drug: TQB3617 Capsules

Interventions

TQ05105 Tablets DRUG

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

TQ05105 Tablets + TQB3617 Capsules

TQB3617 Capsules DRUG

TQB3617 Capsules is a Bromodomain and Extra-Terminal (BET) Inhibitor

TQ05105 Tablets + TQB3617 Capsules

Eligibility Criteria

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

You may qualify if:

• 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.

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 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;

Sponsors & Collaborators

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

Study Sites (22)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 525000, China

NOT YET RECRUITING

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, 530016, China

NOT YET RECRUITING

Cangzhou People's Hosipital

Cangzhou, Hebei, 061014, China

NOT YET RECRUITING

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067020, China

NOT YET RECRUITING

North China of Science and Technology University Affiliated Hospital

Tangshan, Hebei, 063000, China

NOT YET RECRUITING

Xingtai People's Hospital

Xingtai, Hebei, 054031, China

NOT YET RECRUITING

The First Hospital of Harbin

Harbin, Heilongjiang, 150010, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430071, China

NOT YET RECRUITING

Union Hospital Tongji College Huazhong Unizersity of Science And Technology

Wuhan, Hubei, 430071, China

NOT YET RECRUITING

Wuhan University Zhongnan Hospital

Wuhan, Hubei, 430071, China

NOT YET RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010000, China

NOT YET RECRUITING

The Public Hospital of Wuxi

Wuxi, Jiangsu, 214000, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

Xi 'An Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Tai'an City Central Hospital

Tai’an, Shandong, 271099, China

NOT YET RECRUITING

Central Hospital Of Minhang District, Shanghai

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 046000, China

NOT YET RECRUITING

People's Hospital of Tianjin City

Tianjin, Tianjin Municipality, 300122, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

NOT YET RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chunkang Chang, Doctor

CONTACT

13764643870; changchunkang7010@aliyun.com

Luxi Song, Master

CONTACT

18930173187; songluxi@139.com

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: November 2, 2023
• First Posted: November 8, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (22)