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

C

CTTQ

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Myelofibrosis

Treatments

Drug: TQB3617 Capsules
Drug: TQ05105 Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT06122831
TQ05105-TQB3617-Ib/II-01

Details and patient eligibility

About

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.

Enrollment

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.
  • Patients with poor efficacy of JAK inhibitors (for phase Ib and phase II cohort 2)
  • 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 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 BET inhibitors;
  • Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
  • Use of any MF medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to 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;
  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 1 patient group

TQ05105 Tablets + TQB3617 Capsules
Experimental group
Description:
TQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle.
Treatment:
Drug: TQ05105 Tablets
Drug: TQB3617 Capsules

Trial contacts and locations

20

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Central trial contact

Chunkang Chang, Doctor; Luxi Song, Master

Data sourced from clinicaltrials.gov

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