A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera… (NCT06343805) | Clinical Trial Compass
RecruitingPhase 1
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)
United States76 participantsStarted 2024-10-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0.
Timeframe: Baseline through study completion, an average of 1 year
2
Number of patients with Dose Limiting Toxicities (DLTs)
Timeframe: Baseline through study completion, an average of 1 year
3
To establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AJ1-11095
Timeframe: Baseline through study completion, an average of 1 year