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

ZGJAKUS001

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

2024-07-01

2025-05-31

2025-11-30

Recruiting

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

2024-03-21