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)
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.
• 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.
• MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.
• ECOG PS of 0, 1, 2, or 3.
• Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.
• ANC ≥1.0×10\^9/L.
• Platelet count ≥75×10\^9/L.
⁃ eGFR ≥45 mL/min/1.73m2.
⁃ Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
⁃ AST and ALT ≤3.0 × ULN.
⁃ QTcF ≤480 msec.