Health Trials

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 MyelofibrosisPost-Essential Thrombocythemia MyelofibrosisPost-Polycythemia Vera MyelofibrosisPMFPPV-MFPET-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

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Ajax Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov