Actively Recruiting
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)
Led by Ajax Therapeutics, Inc. · Updated on 2026-05-12
76
Participants Needed
21
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AJ1-11095, an oral type II JAK2 inhibitor, in adults with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not responded to or relapsed after prior treatment with at least one type I JAK2 inhibitor. This phase 1, non-randomized, open-label trial aims to assess the safety, tolerability, pharmacokinetics, clinical activity, and biomarker changes of AJ1-11095 in this patient group. The study includes a dose escalation phase followed by an expansion phase to identify the best dose for future studies.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF)
- DIPSS Intermediate-2 or High-risk myelofibrosis with 10% or fewer blasts, regardless of JAK2 mutation status
- Estimated spleen volume of at least 450 cm3
- Total Symptom Score (TSS) of 10 or higher on MFSAF v.4.0, or at least 2 of 7 symptoms with scores of 3 or higher
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
- Prior treatment with at least one type I JAK2 inhibitor and either failed to respond or relapsed
- Absolute neutrophil count (ANC) of at least 1.0 x 10^9/L
- Platelet count of at least 75 x 10^9/L
- Estimated glomerular filtration rate (eGFR) of at least 45 mL/min/1.73m2
- Serum total bilirubin less than or equal to 2.0 times the upper limit of normal (ULN)
- AST and ALT less than or equal to 3.0 times ULN
- QTcF less than or equal to 480 milliseconds
You will not qualify if you...
- Prior splenectomy
- Splenic irradiation within 3 months before first dose of study drug
- Ongoing use of systemic corticosteroids equivalent to more than 10 mg/day of prednisone
- Uncontrolled illnesses such as acute infections
- Chronic active or acute hepatitis B or C infection
- Chemotherapy within 4 weeks before first dose of study drug (Hydrea allowed until 5 days before starting study treatment)
- Use of a type I JAK2 inhibitor less than 5 days or 5 half-lives before dosing
- Use of erythropoiesis stimulating agents unless stable for more than 8 weeks
- Peripheral neuropathy of grade 2 or higher (NCI CTCAE v 5.0)
- Unable or unwilling to undergo CT or MRI for spleen imaging
- Pregnant or breastfeeding
- Need for medications that are strong CYP3A4 inhibitors as concurrent treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year, depending on individual treatment duration
Participants receive oral doses of AJ1-11095 to evaluate safety, tolerability, and establish the recommended phase 2 dose. Treatment involves sequential dose escalation and an expansion phase.
Multiple visits for dosing and safety assessments during treatment cycles
Trial Site Locations
Total: 21 locations
1
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
2
Moffitt Cancer Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
David H. Koch Center for Cancer Care at Memorial Sloan Kettering
New York, New York, United States, 10021
Actively Recruiting
9
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
10
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
11
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
12
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
AP-HP Hopital Saint-Louis
Paris, France
Actively Recruiting
15
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, Italy, Italy
Not Yet Recruiting
16
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, Italy
Not Yet Recruiting
17
Hospital General Universitario Gregorio Maranon
Madrid, Spain, Spain
Actively Recruiting
18
Hospital Clinic Barcelona
Barcelona, Spain
Actively Recruiting
19
Hospital Universitario Ramon y Cajal
Madrid, Spain
Actively Recruiting
20
Guy's Hospital
London, UK, United Kingdom
Not Yet Recruiting
21
Genesis Cancer Care UK Limited - Oxford
Oxford, UK, United Kingdom
Not Yet Recruiting
Research Team
D
David Steensma, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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