Not Yet RecruitingPhase 2

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

China51 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Proportion of subjects with ≥35% reduction in spleen volume from baseline at week 24 (SVR35)

Timeframe: up to 24 weeks

Peak concentration (Cmax)

Timeframe: 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)

Elimination half-life (t1/2)

Area under the curve from time 0 to last measurable concentration (AUC0-t)

Area under the curve from time 0 to infinity (AUC0-∞)

Trial details

NCT IDNCT07551427

SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Chunkang Chang, Doctor

13764643870 changchunkang7010@aliyun.com

View on ClinicalTrials.gov More Myelofibrosis trials