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)
Start Date
10/23/2024
Completion Date
2/15/2027
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.
Detailed Description
This is a phase 1, non-randomized, open-label study utilizing a 3+3 sequential dose escalation design followed by an expansion phase. The primary objective will be to evaluate the safety and tolerability of AJ1-11095, and establish a Maximally Tolerated Dose (MTD) and/or inform the establishment of a candidate Recommended Phase 2 dose (RP2D). The RP2D may be the maximally tolerated dose (MTD) or may be a dose below the MTD. The candidate RP2D will be based on AE pattern, PK and biomarker information, in addition to all available safety and efficacy data. Expansion cohorts will be enrolled to gather additional safety and efficacy information and to further refine input for future RP2D discussions. Eligible participants will have PMF, PPV-MF or PET-MF and will have either have relapsed after a response, or be refractory to, at least one prior type I JAK2 inhibitor therapy, either administered as monotherapy or in combination with another drug.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AJ1-11095
Conditions
Locations
Stanford Cancer Institute
Palo Alto, California 94304
United States
Moffitt Cancer Cancer Center
Tampa, Florida 33612
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering
New York, New York 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
University of Cincinnati
Cincinnati, Ohio 45221
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
AP-HP Hopital Saint-Louis
Paris,
France
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, Italy
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Italy
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Spain
Hospital Clinic Barcelona
Barcelona,
Spain
Hospital Universitario Ramon y Cajal
Madrid,
Spain
Guy's Hospital
London, UK
United Kingdom
Genesis Cancer Care UK Limited - Oxford
Oxford, UK
United Kingdom