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

NCT07802405 | Recruiting Phase 1

• 1 other identifier: JS110-002-I（T）
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MF With Splenomegaly

Outcome Measures

Primary Outcomes (4)

• DLT

  Incidence of DLT

  12 months

• AE

  incidence and severity of adverse events(AEs) and serious adverse events(SAEs),as well as abnormal changes in clinical significance laboratory tests and other examinations

  4 years

• MTD

  Evaluate the Maximum tolerated dose

  12 months

• RP2D

  Evaluate the recommended dose for phase II

  12 months

Secondary Outcomes (9)

• Pharmacokinetic (PK) Parameter

  1.5 years

• SVR35

  4 years

• Score in MPN-SAF-TSS

  4 years

• incidence and severity of adverse events and serious adverse events

  4 years

• ORR：CR + PR + clinical improvement

  4 years

Study Arms (1)

WJ01024 tablet

EXPERIMENTAL

Drug: WJ01024 tablet

Interventions

WJ01024 tablet DRUG

5-20mg BID (dosage per investigator judgement)

WJ01024 tablet

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily participated in this study after obtaining full informed consent and signed the informed consent form.
• Age ≥18 years old, gender not limited;
• Patients diagnosed with primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or patients diagnosed with post-essential thrombocythemia MF (PET-MF) or post-polycythemia vera MF (PPV-MF) according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria;
• Patients evaluated as intermediate-1, intermediate-2, or high-risk according to the International Prognostic System (DIPSS) scoring system;;
• Expected life expectancy is ≥ 24 weeks;
• Eastern Cooperative Oncology Group (ECOG) score of 0-2 ;
• No planned for stem cell transplantation in the near future.
• Splenomegaly: Palpation of the spleen margin reaches or exceeds at least 5cm below the costal margin (the distance from the costal margin to the farthest point of the spleen protrusion), or spleen volume ≥450cm ³ by CT or MRI.
• Adequate hematological and organ function within 7 days before the first administration of the study drug (no RBC transfusion, growth factors, colony-stimulating factors, platelet-generating factors ,or platelet transfusion within 14 days before the testing) :
• Absolute neutrophil count (ANC) ≥1.5×109/L;
• Platelet count ≥75×109/L(Phase IA); Platelet count ≥100×109/L(Phase IB); Hemoglobin ≥ 8.0g /dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Creatinine ≤1.5×ULN.
• For women of childbearing age, within 7 days before the first administration, if the serum pregnancy test is confirmed to be negative and they agree to use effective contraceptive measures during the study drug period and within 90 days after the last administration. For male subjects whose sexual partners are women of childbearing age, they must agree to take effective contraceptive measures during the use of the study drug and within 90 days after the last administration.

You may not qualify if:

• Peripheral blood blasts \>5% or Bone marrow blasts \>10%.
• Previous treatment with XPO1 inhibitors.
• Unable to cooperate with or unable to perform MRI or CT scans as deemed necessary by sponsor and investigator
• Treatment with strong CYP3A inhibitors or inducers within 14 days prior to initial administration"

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Central Study Contacts

Shuai Guo

CONTACT

15902401702; sguo@wigenbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study consisted of two phases: Phase IA and Phase IB. Phase IA: Patients with myelofibrosis who have relapsed, are refractory or intolerant after treatment with JAK inhibitors Phase IB: Patients with intermediate- or high-risk myelofibrosis who have not previously received JAK inhibitor treatment

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 3, 2026
• Study Start: November 21, 2023
• Primary Completion: September 26, 2026
• Study Completion (Estimated): November 21, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)