A Safety and Tolerability Study of Jaktinib

Phase 1

Recruiting

• Conditions: Myelofibrosis
• Interventions: Drug: Jaktinib Hydrochloride Tablet

• Registration Number: NCT05279001
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.

Detailed Description

This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Study Start: 2024-07-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
• Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
• At least 18 years of age.
• ECOG PS 0, 1, or 2.
• Expected life expectancy is greater than 24 weeks.

Exclusion Criteria

• Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
• Major surgery or radiation therapy within 28 days prior to initiation of study drug.
• With suspected allergies to jaktinib or its excipient.
• Another clinical trial of a new drug or medical instrument within 3 months before screening.
• Females who are pregnant, currently breastfeeding, planning to become pregnant.
• Unable to adopt effective contraceptive methods during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jaktinib	Jaktinib Hydrochloride Tablet	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets	28 days	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Safety of jaktinib hydrochloride tablets	At least 24 weeks, up to approximately 1 year for follow-up	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic characteristics of jaktinib hydrochloride tablets	7 days	Volume of distribution
Efficacy of jaktinib hydrochloride tablets	at least 24 weeks, up to approximately 1 year	reduction of total symptoms score (TSS) of ≥50%

Trial Locations

Locations (1)

Site 01; 🇺🇸 Canton, Ohio, United States