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)

ConditionsPrimary Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis Post-Polycythemia Vera Myelofibrosis PMF PPV-MF PET-MF

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorAjax Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

18 years of age or older.

Diagnosis of PMF, post-PV MF, or post-ET MF.

DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status.

Estimated spleen volume ≥450cm3.

Disqualifiers

Prior splenectomy.

Splenic irradiation within 3 months prior to first dose of study drug.

Ongoing use of systemic corticosteroids at dose equivalent to >10mg/day of prednisone.

Uncontrolled intercurrent illness such as an acute infection.

Trial design

Treatments tested in this trial

AJ1-11095

Treatment groups

76 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Locations

France

AP-HP Hopital Saint-Louis Paris France

Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola BolognaItaly, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico MilanItaly, Italy

Spain

Hospital General Universitario Gregorio Maranon MadridSpain, Spain

Sponsors and collaborators

Ajax Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov