Clinical Trial 23308

• Overview

  Study Title:

  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)

  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.

  Objective:

  Primary Objectives: To evaluate the safety and tolerability of AJ1-11095. To establish the maximum tolerated dose(s) (MTD[s]) and/or recommended Phase 2 dose(s) (RP2D[s]) of AJ1-11095. Secondary Objectives: To assess clinical response to AJ1-11095 administration in patients with MF who were previously treated with at least one Type I JAK2 inhibitor. To evaluate the PK of AJ1-11095 and its metabolite AJ1-11101.

• Treatments

  Therapies:

  Tyrosine Kinase Inhibitor

  Medications:

  AJ1-11095 ()

• Inclusion Criteria

  Inclusion Criteria:
  • 18 years of age or older.
  • Diagnosis of Primary Myelofibrosis (PMF), Post-polycythemia vera Myelofibrosis (post-PV MF), or Post-essential thrombocythemia (post-ET MF).
  • Dynamic International Prognostic Scoring System (DIPSS) Intermediate-2 or High-risk MF 10% or less blasts, regardless of JAK2 mutation status.
  • Estimated spleen volume 450cm3 or greater.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (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.
  • Adequate Organ Function.
  • Other criteria may apply

• Exclusion Criteria

  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.
  • 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 JAK2 inhibitor in the previous 10 days.
  • Use of erythropoiesis stimulating agents (unless stable for >8 weeks).
  • 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.
  • Other criteria may apply

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