A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Intermediate- and High-risk Myelofibrosis

Status: Recruiting
Location: See all (22) 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 TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis.

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

• 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.

Locations
Other Locations
China
Cangzhou People's Hosipital
NOT_YET_RECRUITING
Cangzhou
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Heping Hospital Affiliated to Changzhi Medical College
NOT_YET_RECRUITING
Changzhi
Affiliated Hospital of Chengde Medical College
NOT_YET_RECRUITING
Chengde
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
The First Hospital of Harbin
NOT_YET_RECRUITING
Harbin
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Guangxi Zhuang Autonomous Region People's Hospital
NOT_YET_RECRUITING
Nanning
Central Hospital Of Minhang District, Shanghai
NOT_YET_RECRUITING
Shanghai
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Sixth People's Hospital
RECRUITING
Shanghai
Tai'an City Central Hospital
NOT_YET_RECRUITING
Tai’an
North China of Science and Technology University Affiliated Hospital
NOT_YET_RECRUITING
Tangshan
People's Hospital of Tianjin City
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital Tongji College Huazhong Unizersity of Science And Technology
NOT_YET_RECRUITING
Wuhan
Wuhan University Zhongnan Hospital
NOT_YET_RECRUITING
Wuhan
The Public Hospital of Wuxi
NOT_YET_RECRUITING
Wuxi
Xi 'An Jiaotong University Second Affiliated Hospital
NOT_YET_RECRUITING
Xi'an
Xingtai People's Hospital
NOT_YET_RECRUITING
Xingtai
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Chunkang Chang, Doctor
changchunkang7010@aliyun.com
13764643870
Backup
Luxi Song, Master
songluxi@139.com
18930173187
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2027-04
Participants
Target number of participants: 92
Treatments
Experimental: TQ05105 Tablets + TQB3617 Capsules
TQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle.~TQB3617 Capsules, orally administered, 21 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov