A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Moderate- and High-risk Myelofibrosis

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital Zhejiang University School Of Medicine
RECRUITING
Hangzhou
The Second People's Hospital of Hefei
NOT_YET_RECRUITING
Hefei
People's Hospital of Tianjin
NOT_YET_RECRUITING
Tianjin
Xijing Hospital of the Fourth Military Medical University
NOT_YET_RECRUITING
Xi'an
Hennan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Hong yan Tong, Doctor
tonghongyan@zju.edu.cn
13958122357
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2027-05
Participants
Target number of participants: 93
Treatments
Experimental: TQB3909 Tablets
TQB3909 Tablets, orally administered. 28 days as a treatment cycle.
Experimental: TQ05105 Tablets combined with TQB3909 Tablets
TQ05105 Tablets combined with TQB3909 Tablets, orally administered. 28 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov