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A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)
Sponsor: Ajax Therapeutics, Inc.
Summary
AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.
Official title: A Multicenter, Open-Label, Phase 1 Study of AJ1-11095 Administered as Oral Monotherapy in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2024-10-23
Completion Date
2027-02-15
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
AJ1-11095
Type II JAK2 Inhibitor
Locations (16)
Stanford Cancer Institute
Palo Alto, California, United States
Moffitt Cancer Cancer Center
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
AP-HP Hopital Saint-Louis
Paris, France
Hospital Clinic Barcelona
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain