A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis

A Phase II, Single-arm, Open-label, Multicenter Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis

This is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing. Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate/high-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.

Study Overview

• Status: Recruiting
• Conditions: Myelofibrosis
• Intervention / Treatment: Drug: TQ05105 Tablets (Rovadicitinib Tablets)

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chunkang Chang, Doctor; Phone Number: 13764643870; Email: changchunkang7010@aliyun.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Xiaoyu Zhu, Doctor; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Yong Wu, Doctor; Phone Number: 13365910911; Email: wuyong9195@126.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First Municipal People's Hospital
      • Contact: Shunqing Wang, Doctor; Phone Number: 13437807998; Email: drwangshq@medmail.com.cn
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Zhenfang Liu, Doctor; Phone Number: 13481082237; Email: liuliuzhenfang@163.com
  • Hebei
    • Cangzhou, Hebei, China, 061014
      • Recruiting
      • Cangzhou People's Hospital rovince
      • Contact: Hongmei Ma, Master; Phone Number: 18031798229; Email: mhm-sspc@163.com
    • Chengde, Hebei, China, 067000
      • Recruiting
      • Affiliated Hospital of Chengde Medical College
      • Contact: Zhihua Zhang, Master; Phone Number: 15633142905; Email: zzhangzhihua@163.com
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Xuejun Zhang, Doctor; Phone Number: 13722781112; Email: zhxjhbmu@126.com
    • Xingtai, Hebei, China, 054000
      • Recruiting
      • Xingtai People's Hospital
      • Contact: Zongjiu Jiao, Master; Phone Number: 18631921299; Email: 1449569258@qq.com
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Hu Zhou, Doctor; Phone Number: 13939068863; Email: papertigerhu@163.com
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
      • Contact: Zhenya Hong, Postdoctoral; Phone Number: 13476158466; Email: hongzhenya@sina.com
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Union Hospital Tongji College Huazhong University of Science and Technology
      • Contact: Min Zhang, Doctor; Phone Number: 15871818568; Email: Zhangmin35@aliyun.com
  • Hunan
    • Zhuzhou, Hunan, China, 412000
      • Recruiting
      • ZhuZhou Central Hospital
      • Contact: Chanjuan Shen, Master; Phone Number: 18973389928; Email: shenchanjuan@163.com
  • Jiangsu
    • Nanjin, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Bing Chen, Doctor; Phone Number: 13951806490; Email: chenbinggcp@163.com
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Provincial Hospital of Traditional Chinese Medicine
      • Contact: Xuejun Zhu, Doctor; Phone Number: 13505152806; Email: zhuxj2@sina.com
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First hospital of Jilin University
      • Contact: Sujun Gao, Doctor; Phone Number: 15843073208; Email: sujung1963@163.com
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • Shengjing Hospital Affiliated to China Medical University
      • Contact: Huihan Wang, Doctor; Phone Number: 18940256966; Email: wanghh@sj-hospital.org
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Pengcheng He, Doctor; Phone Number: 18991232609; Email: hpec_gcp@163.com
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • The First Affiliated Hospital of Air Force Medical University
      • Contact: Guangxun Gao, Doctor; Phone Number: 13991907320; Email: gaoguangxun@fmmu.edu.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200233
      • Recruiting
      • Shanghai Sixth People's Hospital
      • Contact: Chunkang Chang, Doctor; Phone Number: 13764643870; Email: changchunkang7010@aliyun.com
  • Shanxi
    • Changzhi, Shanxi, China, 046000
      • Recruiting
      • Heping Hospital Affiliated to Changzhi Medical College
      • Contact: Xuliang Shen, Doctor; Phone Number: 13015365546; Email: shenxlcyp@sohu.com
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Xiaobing Huang, Doctor; Phone Number: 18981838236; Email: hxb_trial@163.com
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 301617
      • Recruiting
      • Chinese Academy of Medical Sciences Hematology Hospital
      • Contact: Bo Jiang, Doctor; Phone Number: 18630810181; Email: jiangbo@ihcams.as.cn
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • Recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Jianping Hao, Master; Phone Number: 13579876416; Email: 13579876416@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Hongyan Tong, Doctor; Phone Number: 13958122357; Email: hongyantong@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary and signed informed consent, good compliance.
2. Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.
3. Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria; Janus kinase 2 (JAK2) mutation status not restricted.
4. Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).
5. Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with refractory, relapsed, or intolerant.
6. Spleen enlargement (except Cohort 1).
7. Peripheral blood and bone marrow blasts ≤10%.
8. No growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks before first dose; and routine blood parameters meet requirements within 7 days before first dose.
9. Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).
10. Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.

Exclusion Criteria:

1. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.
2. Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
3. Prior splenectomy or splenic radiotherapy within 6 months before first dose.
4. Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
5. Factors affecting oral drug absorption.
6. Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).
7. Major surgery or significant traumatic injury within 4 weeks before first dose.
8. Congenital bleeding or coagulation disorders.
9. Arterial/venous thrombosis event within 6 months before first dose.
10. History of substance abuse or mental disorder.
11. Active or uncontrolled severe infection.
12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
13. Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.
14. Uncontrolled hypertension despite standard therapy.
15. Renal failure requiring hemodialysis or peritoneal dialysis.
16. Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.
17. History of immunodeficiency or organ transplantation.
18. Epilepsy requiring treatment.
19. Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.
20. Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.
21. Uncontrolled pleural effusion, pericardial effusion, or ascites.
22. Live attenuated vaccine within 4 weeks before first dose or planned during the study.
23. Known hypersensitivity to study drug or excipients.
24. Diagnosis of active autoimmune disease within 2 years before first dose.
25. Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose.
26. Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQ05105 Tablets; TQ05105 Tablets, 28 days as a treatment cycle.	Drug: TQ05105 Tablets (Rovadicitinib Tablets); TQ05105 is an inhibitor of Janus kinase 1 (JAK1), Janus kinase 2 (JAK2), and Rho-associated coiled-coil containing protein kinase 1 (ROCK1) and 2 (ROCK2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with ≥35% reduction in spleen volume from baseline at week 24 (SVR35)	SVR35 at week 24 as assessed by Independent Review Committee (IRC)	up to 24 weeks
Peak concentration (Cmax)	Maximum plasma concentration of TQ05105 and its metabolite(s).	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Time to peak concentration (Tmax)	Time to reach maximum plasma concentration of TQ05105 and its metabolite(s).	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Elimination half-life (t1/2)	Half-life of TQ05105 and its metabolite(s) in plasma.	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Area under the curve from time 0 to last measurable concentration (AUC0-t)	AUC from time 0 to the last measurable concentration of TQ05105 and its metabolite(s).	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Area under the curve from time 0 to infinity (AUC0-∞)	AUC from time 0 extrapolated to infinity for TQ05105 and its metabolite(s).	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Total clearance (CLt)	Total body clearance of TQ05105 and its metabolite(s) from plasma.	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Renal clearance (CLr)	Renal clearance of TQ05105 and its metabolite(s).	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Apparent volume of distribution (Vd/F)	Apparent volume of distribution of TQ05105 and its metabolite(s) after oral administration.	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Elimination rate constant (λz)	Terminal elimination rate constant of TQ05105 and its metabolite(s).	Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best response rate of spleen volume reduction	Proportion of subjects with at least one occurrence of ≥35% reduction in spleen volume from baseline.	up to 48 weeks
Onset time of splenic response	The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from the baseline.	up to 48 weeks
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)	Duration of spleen volume reduction ≥ 35% from baseline: the time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction < 35% from baseline.	up to 48 weeks
Percentage change in spleen volume from baseline at planned visits	Percentage change in spleen volume relative to baseline at each planned visit.	up to 48 weeks
SVR35 at each planned visit time point	Proportion of subjects with ≥35% reduction in spleen volume from baseline at each planned visit.	up to 48 weeks
The proportion of subjects whose total symptom score of Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) decreased by more than 50% compared with baseline.	The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% compared with baseline. Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF-TSS) is an effective tool for evaluating the disease burden of patients with myeloproliferative neoplasms. The higher the score, the more severe the symptoms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels,The sum of the symptom scores is the MPN-SAF-TSS score.	up to 48 weeks
Percentage change in MPN-SAF TSS from baseline at planned visits	Percentage change in MPN-SAF TSS from baseline at planned visits.	up to 48 weeks
Proportion of subjects with at least one occurrence of ≥50% reduction in MPN-SAF TSS from baseline	Proportion of subjects with at least one occurrence of ≥50% reduction in MPN-SAF TSS from baseline.	up to 48 weeks
Time to first ≥50% reduction in MPN-SAF TSS from baseline	Time from first dose to first documentation of ≥50% reduction in MPN-SAF TSS from baseline.	up to 48 weeks
Duration of ≥50% reduction in MPN-SAF TSS from baseline	Time from first achievement of ≥50% reduction in MPN-SAF TSS to loss of this response.	up to 48 weeks
Objective response rate (ORR)	Proportion of subjects achieving complete remission (CR) or partial remission (PR).	up to 48 weeks
Progression-free survival (PFS)	The time interval from the first medication to the date of the occurrence of any of the following events, whichever occurs first, shall prevail :(1) Spleen volume increased by≥25% compared with the screening period ; (2) Death caused by any cause.	From first dose to event (up to study completion) , an average of 3 years
Leukemia free survival (LFS)	Time from first dose to leukemic transformation or death.	From first dose to event (up to study completion) , an average of 3 years
Overall Survival (OS)	OS is defined as the time from the first time the subject received treatment to death due to any cause	From first dose to event (up to study completion) , an average of 3 years
Incidence of adverse events (AEs)	Incidence of adverse events determined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.	From baseline up to 4 weeks after last dose
Severity of AEs	All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the CTCAE v6.0.	From baseline up to 4 weeks after last dose
Urinary excretion amount (Ae0-24)	Amount of drug excreted in urine within 24 hours after single and multiple oral doses of TQ05105.	Pre-dose (-24-0 hours), 0-3, 3-6, 6-9, 9-12, 12-24 hours post-dose
Cumulative urinary excretion rate (Ae0-24%)	Percentage of the dose excreted in urine within 24 hours after single and multiple oral doses of TQ05105.	Pre-dose (-24-0 hours), 0-3, 3-6, 6-9, 9-12, 12-24 hours post-dose
Proportion of subjects receiving red blood cell transfusion within 24 weeks	Proportion of subjects who receive red blood cell transfusion during the first 24 weeks of treatment.	Up to 24 weeks
Proportion of subjects receiving platelet transfusion within 24 weeks	Proportion of subjects who receive platelet transfusion during the first 24 weeks of treatment.	Up to 24 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Primary Myelofibrosis
• Other Study ID Numbers: TQ05105-II-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No