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

NCT07551427 | Not Yet Recruiting Phase 2

• 1 other identifier: TQ05105-II-08
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (20)

• Best response rate of spleen volume reduction

  up to 48 weeks

• Onset time of splenic response

  up to 48 weeks

• Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)

  up to 48 weeks

• Percentage change in spleen volume from baseline at planned visits

  up to 48 weeks

• SVR35 at each planned visit time point

  up to 48 weeks

Study Arms (1)

TQ05105 Tablets

EXPERIMENTAL

TQ05105 Tablets, 28 days as a treatment cycle.

Drug: TQ05105 Tablets (Rovadicitinib Tablets)

Interventions

TQ05105 Tablets (Rovadicitinib Tablets) DRUG

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).

TQ05105 Tablets

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 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.
• 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.
• Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).
• 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.
• Spleen enlargement (except Cohort 1).
• Peripheral blood and bone marrow blasts ≤10%.
• 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.
• Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).
• Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.

You may not qualify if:

• Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.
• Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
• Prior splenectomy or splenic radiotherapy within 6 months before first dose.
• Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
• Factors affecting oral drug absorption.
• Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).
• Major surgery or significant traumatic injury within 4 weeks before first dose.
• Congenital bleeding or coagulation disorders.
• Arterial/venous thrombosis event within 6 months before first dose.
• History of substance abuse or mental disorder.
• Active or uncontrolled severe infection.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.
• Uncontrolled hypertension despite standard therapy.
• Renal failure requiring hemodialysis or peritoneal dialysis.

Sponsors & Collaborators

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

Study Sites (24)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530000, China

Location

Cangzhou People's Hospital rovince

Cangzhou, Hebei, 061014, China

Location

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Xingtai People's Hospital

Xingtai, Hebei, 054000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

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

Wuhan, Hubei, 430071, China

Location

Union Hospital Tongji College Huazhong University of Science and Technology

Wuhan, Hubei, 430071, China

Location

Zhuzhou Central Hospital

Zhuzhou, Hunan, 412000, China

Location

Nanjing Drum Tower Hospital

Nanjin, Jiangsu, 210000, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, 710000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Heping Hospital Affiliated To Changzhi Medical College

Changzhi, Shanxi, 046000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

Location

Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, Tianjin Municipality, 301617, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-02

Locations

CN (24)