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RECRUITING
NCT07802405
PHASE1

Evaluating Safety ,Tolerability, Pharmacokinetic,Efficacy of WJ01024 or WJ01024 Combined With Ruxolitinib in Patients With Myelofibrosis

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

WJ01024 tablet

5-20mg BID (dosage per investigator judgement)

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China