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)

Description

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.

Conditions

Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, PMF, PPV-MF, PET-MF

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Study Overview

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Study Details

Study overview

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.

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)

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)

Condition
Primary Myelofibrosis
Intervention / Treatment

-

Contacts and Locations

Tampa

Moffitt Cancer Cancer Center, Tampa, Florida, United States, 33612

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

David H. Koch Center for Cancer Care at Memorial Sloan Kettering, New York, New York, United States, 10021

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45221

Columbus

The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ajax Therapeutics, Inc.,

John Mascarenhas, M.D., PRINCIPAL_INVESTIGATOR, Mt. Sinai

Study Record Dates

2027-02-15