A Safety and Tolerability Study of Jaktinib

Myelofibrosis Clinical Trial

Official title:

A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279001
• Other study ID #: ZGJAKUS001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Jason Wu, M.D
• Phone: +86-21-58942758
• Email: wujs[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Intervention

Drug:
• Jaktinib Hydrochloride Tablet
Orally administered, twice a day

Locations

Country	Name	City	State
United States	Site 01	Canton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of jaktinib hydrochloride tablets	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	At least 24 weeks, up to approximately 1 year for follow-up
Primary	Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	28 days
Secondary	Efficacy of jaktinib hydrochloride tablets	reduction of spleen volume of =35%	at least 24 weeks, up to approximately 1 year
Secondary	Efficacy of jaktinib hydrochloride tablets	reduction of total symptoms score (TSS) of =50%	at least 24 weeks, up to approximately 1 year
Secondary	Pharmacokinetic characteristics of jaktinib hydrochloride tablets	Peak Plasma Concentration (Cmax)	7 days
Secondary	Pharmacokinetic characteristics of jaktinib hydrochloride tablets	Time to maximum concentration (Tmax)	7 days
Secondary	Pharmacokinetic characteristics of jaktinib hydrochloride tablets	Half-life (T1/2)	7 days
Secondary	Pharmacokinetic characteristics of jaktinib hydrochloride tablets	Clearance (CL/F)	7 days
Secondary	Pharmacokinetic characteristics of jaktinib hydrochloride tablets	Area under Curve (AUCinf)	7 days
Secondary	Pharmacokinetic characteristics of jaktinib hydrochloride tablets	Volume of distribution	7 days