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)
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)
Ajax Therapeutics, Inc.
76 participants
Oct 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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.
Exclusion Criteria12
- 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.
- Chronic active or acute hepatitis B or C infection.
- Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).
- Use of a Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer).
- Use of erythropoiesis stimulating agents (unless stable for \>8 weeks).
- Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
- Unable or unwilling to undergo CT or MRI for spleen size imaging.
- Pregnant or breastfeeding.
- Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.
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Interventions
Type II JAK2 Inhibitor
Locations(16)
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NCT06343805