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)

Recruiting Phase 1 Interventional Study
Primary Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis Post-Polycythemia Vera Myelofibrosis PMF PPV-MF PET-MF
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
76 (estimated)
Sponsor
Ajax Therapeutics, Inc. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older. 2. Diagnosis of PMF, post-PV MF, or post-ET MF. 3. DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status. 4. Estimated spleen volume ≥450cm3. 5. MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with …
Contacts

David Steensma, M.D.

917-410-7250

david@ajaxtherapeutics.com

CONTACT