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Phase 1 Study of AJ1-11095 for Myelofibrosis

This study is testing a new oral medication called AJ1-11095 for people with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF). These are types of bone marrow disorders where scar tissue builds up. You might be able to join if you are 18 or older, have one of these conditions, and have already tried a different type of JAK2 inhibitor medication that didn't work well enough. The main goal is to find out how safe AJ1-11095 is, what side effects it might cause, and to determine the best dose for future studies. The study aims to enroll about 76 participants. The current status of this study is unclear.

Study design
This is a Phase 1, non-randomized, open-label study, meaning everyone knows what treatment they are receiving. It will involve about 76 participants and uses a step-by-step dose increase to find the safest and most effective dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the start of the study through its completion, which is expected to be about one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06343805

A Phase 1 Study of LY5830966 in Participants 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
PHASE1Ages 18+InterventionalTreatment
Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
~256 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:LY5830966

At a glance

Recruiting sites
17 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).
Measured over Baseline through study completion, an average of 1 year
+2 more outcomes measured

Conditions

Primary Myelofibrosis

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NCT06343805

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Guy's Hospital

    London, UK, United Kingdomstudy coordinator listed

    Not yet recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, Spain, Spainstudy coordinator listed

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Moffitt Cancer Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

David Steensma, M.D.
[email protected]
917-410-7250
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of PMF, post-PV MF, or post-ET MF.
Dynamic International Prognostic Scoring System (DIPSS) Intermediate-1, Intermediate-2 or High-risk MF with less than or equal to (≤)10% blasts, regardless of JAK2 mutation status.
Estimated spleen volume greater than or equal to (≥)450 cubic centimeter (cm ³)
Myelofibrosis Symptom Assessment Form, version 4.0 (MFSAF v.4.0) TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.
Eastern Cooperative Oncology Group performance score (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.
Absolute neutrophil count greater than or equal to 1,000 per microliter of blood (ANC ≥1.0×10\^9/L).
Platelet count ≥75×10\^9/L.
Estimated glomerular filtration rate greater than or equal to 45 milliliters per minute per 1.73 square meters (eGFR ≥45 mL/min/1.73m²).
Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit normal (ULN).
QTcF ≤470 msec.
Confirmed diagnosis of PV
Participants must have high-risk disease as defined by 60 years of age or older and/or have prior history of thrombotic event
R/R or intolerant to at least one line of prior therapy including but not limited to interferon-based therapies, ruxolitinib, or hydroxyurea (HU) as defined by European LeukemiaNet (ELN) criteria

Exclusion

Prior splenectomy or splenic irradiation within 3 months.
Ongoing use of systemic corticosteroids at dose equivalent to greater than (\>) 20 milligrams per day (mg/day) of prednisone.
Active, uncontrolled systemic infection or active Hepatitis B or C
Chemotherapy in the previous 4 weeks or prior JAK2 inhibitor not discontinued per required washout prior to first dose
Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
Pregnant or breastfeeding: males planning to father a child during treatment and for 3 months after last dose.
Requirement for therapy with a medication that is a strong Cytochrome P450 3A4 CYP3A4 inhibitor as a concomitant medication.
Currently on an interventional therapeutic trial in the treatment phase.
Significant cardiovascular disease
Active second primary malignancy (or diagnosed within 2 years) at high risk of progression, with standard exceptions (treated skin cancer, in situ cervical cancer, curatively treated localized breast/prostate cancer)
Prolongation of the corrected QTcF ≥470 millisecond during screening
Individual with a history of (noninfectious) pneumonitis/interstitial lung disease.
Prior treatment with JAK2 inhibitors
Prior PV-directed therapy without required washout
Active or chronic bleeding within 2 months prior to enrollment
Clinically significant thrombosis (e.g., pulmonary embolism, deep vein thrombosis, or splenic vein thrombosis) within 2 months prior to enrollment
Requires phlebotomy at hematocrit levels \<45%.

What this trial measures

  • Number of patients with treatment-emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).Baseline through study completion, an average of 1 year

    Treatment Emergent AEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability of LY5830966.

  • Number of patients with Dose Limiting Toxicities (DLTs)Baseline through study completion, an average of 1 year

    Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.

  • To establish the maximum tolerated dose (MTD) and/or recommended phase 3 dose (RP3D) of LY5830966Baseline through study completion, an average of 1 year

    Safety evaluations will occur consistently for each patient and across patients to assess MTD or RP3D. See description of safety evaluations described in outcomes 1 and 2 mentioned above.