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)

Launched by AJAX THERAPEUTICS, INC. · Mar 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AJ1-11095 for patients with specific types of myelofibrosis, which is a serious blood disorder affecting the bone marrow. The trial is designed for adults aged 18 and older who have already tried a different treatment but did not have a good response or their condition got worse. To be eligible, participants should have a diagnosis of primary myelofibrosis or myelofibrosis that developed after having other blood conditions like polycythemia vera or essential thrombocythemia. They also need to have certain symptoms and characteristics, such as a larger-than-normal spleen and specific risk factors related to their condition.

In this trial, participants will receive the new oral medication and will be monitored for its safety and effectiveness, as well as how their bodies process the drug. The study is currently recruiting, and participants can expect regular check-ups and tests to assess their health and response to the treatment. It's important to note that there are some restrictions, like not having had certain treatments recently, so potential participants should discuss their medical history with their doctor to see if they qualify.

Gender

ALL

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 scores ≥3.
• • 6. ECOG PS of 0, 1, 2, or 3.
• • 7. Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.
• • 8. ANC ≥1.0×10\^9/L.
• • 9. Platelet count ≥75×10\^9/L.
• • 10. eGFR ≥45 mL/min/1.73m2.
• • 11. Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
• • 12. AST and ALT ≤3.0 × ULN.
• • 13. QTcF ≤480 msec.
• Exclusion Criteria:
• • 1. Prior splenectomy.
• • 2. Splenic irradiation within 3 months prior to first dose of study drug.
• • 3. Ongoing use of systemic corticosteroids at dose equivalent to \>10mg/day of prednisone.
• • 4. Uncontrolled intercurrent illness such as an acute infection.
• • 5. Chronic active or acute hepatitis B or C infection.
• • 6. Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).
• • 7. Use of a JAK2 inhibitor in the previous 10 days.
• • 8. Use of erythropoiesis stimulating agents (unless stable for \>8 weeks).
• • 9. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
• • 10. Unable or unwilling to undergo CT or MRI for spleen size imaging.
• • 11. Pregnant or breastfeeding.
• • 12. Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.