A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
Key claim: A Phase II open-label single-arm study is evaluating the efficacy, safety, and pharmacokinetics of TQ05105 tablets in intermediate/high-risk myelofibrosis patients who are refractory, relapsed, or intolerant to prior JAK inhibitor therapy.
Abstract
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.
Why this matters
Patients with intermediate/high-risk myelofibrosis who fail or cannot tolerate ruxolitinib or other approved JAK inhibitors have limited options, making post-JAKi salvage agents a critical unmet need. TQ05105 joins a growing pipeline of next-generation JAK inhibitors (alongside flonoltinib maleate, gecacitinib, and AJ1-11095) being tested in this refractory setting, and its inclusion of a dedicated renal-impairment PK cohort may inform dosing in real-world MF populations with comorbidities.