A Safety and Tolerability Study of Jaktinib

March 19, 2024 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jaktinib
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of jaktinib hydrochloride tablets
Time Frame: at least 24 weeks, up to approximately 1 year
reduction of spleen volume of ≥35%
at least 24 weeks, up to approximately 1 year
Efficacy of jaktinib hydrochloride tablets
Time Frame: at least 24 weeks, up to approximately 1 year
reduction of total symptoms score (TSS) of ≥50%
at least 24 weeks, up to approximately 1 year
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time Frame: 7 days
Peak Plasma Concentration (Cmax)
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time Frame: 7 days
Time to maximum concentration (Tmax)
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time Frame: 7 days
Half-life (T1/2)
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time Frame: 7 days
Clearance (CL/F)
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time Frame: 7 days
Area under Curve (AUCinf)
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time Frame: 7 days
Volume of distribution
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZGJAKUS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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