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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07551427
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

First listed
Apr 24, 2026
Start date
Jun 18, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TQ05105 Tablets
    TQ05105 Tablets, 28 days as a treatment cycle.

Primary Outcome Measure

Proportion of subjects with ≥35% reduction in spleen volume from baseline at week 24 (SVR35) [ Time Frame: up to 24 weeks ]

Central Contacts

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