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Evaluating Safety ,Tolerability, Pharmacokinetic,Efficacy of WJ01024 or WJ01024 Combined With Ruxolitinib in Patients With Myelofibrosis
Sponsor: Henan Cancer Hospital
Summary
This is a Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and preliminary efficacy of oral WJ01024 administered as monotherapy and in combination with ruxolitinib in patients with myelofibrosis(MF). The study will be conducted in two phases: Phase IA and Phase IB. Phase IA is a dose-escalation and dose-expansion study of WJ01024 monotherapy in patients with MF after failure of JAK inhibitor (JAKi) therapy (relapsed/refractory/intolerant). Phase IB is a dose-escalation and dose-expansion study of WJ01024 in combination with ruxolitinib in JAKi-naïve patients with intermediate- or high-risk MF.
Official title: A Phase I Clinical Study Evaluating the Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Oral Administration of WJ01024 as a Monotherapy and in Combination With Ruxolitinib in Patients With Myelofibrosis
Key Details
Gender
All
Age Range
18 Days - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-11-21
Completion Date
2027-11-21
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
WJ01024 tablet
5-20mg BID (dosage per investigator judgement)
Locations (1)
Henan Cancer Hospital
Zhengzhou, Henan, China