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)

Recruiting now · Phase 1

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

In brief

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.

Key facts

Study ID

NCT06343805

Run by

Ajax Therapeutics, Inc.

People needed

76

Starts

2024-10-23

Expected to finish

2027-02-15

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Platelet count ≥75×10\^9/L.
• eGFR ≥45 mL/min/1.73m2.
• Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
• AST and ALT ≤3.0 × ULN.
• QTcF ≤480 msec.

You may not qualify if…

• 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 Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer).
• Use of erythropoiesis stimulating agents (unless stable for >8 weeks).
• Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
• 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.

Where it is running

• Stanford Cancer Institute — Palo Alto, California, United States (enrolling)
• Moffitt Cancer Cancer Center — Tampa, Florida, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• AP-HP Hopital Saint-Louis — Paris, France (enrolling)
• Hospital General Universitario Gregorio Maranon — Madrid, Spain, Spain (enrolling)
• Hospital Clinic Barcelona — Barcelona, Spain (enrolling)
• Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
• Guy's Hospital — London, UK, United Kingdom
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola — Bologna, Italy, Italy
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy, Italy
• Genesis Cancer Care UK Limited - Oxford — Oxford, UK, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.