Phase II Study of TQ05105 Tablets to Evaluate Safety, Effectiveness, and Drug Levels in Adults with Intermediate or High-risk Myelofibrosis

What this Trial Is About

This trial investigates TQ05105 tablets in adults with intermediate or high-risk myelofibrosis, a type of bone marrow cancer. It includes two groups one studying how the drug behaves in the body in participants with different levels of kidney function, and another assessing the drugs safety and effect in those who have not responded well or cannot tolerate previous Janus kinase JAK inhibitor treatments. The study is a phase II, open-label, single-arm, multicenter trial. Participants receive TQ05105 tablets in 28-day treatment cycles. The first group focuses on pharmacokinetics to guide dosing for normal to moderate kidney impairment. The second group evaluates the drugs safety and potential benefits in participants with spleen enlargement and prior JAK inhibitor therapy that was ineffective or intolerable. Treatment continues with regular dosing and monitoring. During the study, participants undergo assessments including measurements of spleen volume reduction and various pharmacokinetic parameters such as drug concentration over time. Safety is monitored through recording adverse events during treatment and up to 4 weeks after the last dose. Additional outcomes include symptom assessments, survival rates, and blood transfusion needs. The study lasts up to several years, with primary measurements at 24 weeks and extended follow-up averaging three years.

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