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A Multicenter, Open-Label, Phase 1 Study of AJ1-11095 Administered as Oral Monotherapy in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPVMF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

Primary Investigator
Pettit, Kristen
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06343805
UM Number
2025.072
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
61027
Secondary Protocol No
HUM00276179
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Other Hematopoietic
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 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 Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer).
  •   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.