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Primary MyelofibrosisPhase 1NCT06343805

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)

A Phase 1 study testing LY5830966 in people with Primary Myelofibrosis, run by Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 21 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

J8G-MC-JDIA (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 Janus Kinase 2 (JAK2) inhibitor, LY5830966, in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Myelofibrosis
What is being tested?
LY5830966
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
21 sitesin 5 countries
Study dates
3 Oct 2024to Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.
  • Polycythemia vera (PV) Only
  • 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

Who cannot join

  • 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.
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  • 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.
  • First line (1L) MF only:
  • Prior treatment with JAK2 inhibitors
  • High-risk R/R PV only:
  • 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%.

Trial locations and contacts

21 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

David Steensma, M.D. contact

917-410-7250

david@ajaxtherapeutics.com

21 sites in 5 countries

United States13 sites, 13 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Kristen Pettit, MD, 734-647-2829

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Gabriela Hobbs, MD, 617-724-1124

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Jacqueline Garcia, MD, 617-632-1906

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Michael Grunwald, MD, 980-442-4363

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45221

    Eric Vick, MD, 513-213-3203

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Uma Borate, MD, 614-685-9828

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Prithviraj Bose, MD, 713-792-7747

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Abdulraheem Yacoub, MD

    Recruiting

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering

    New York, New York, 10021

    Raajit Rampal, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    John Mascarenhas, MD, 212-241-8839

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    William Shomali, MD, 650-498-6000

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Stephen Oh, MD, 314-362-8814

    Recruiting

  • Moffitt Cancer Cancer Center

    Tampa, Florida, 33612

    Andrew Kuykendall, MD, 813-745-4639

    Recruiting

Other trials in United States

Spain3 sites, 3 recruiting

  • Hospital Clinic Barcelona

    Barcelona

    Ana Moreno Triguero

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid

    Santiago Osorio-Prendes, MD, 0034915868443

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid

    Valentin Garcia-Gutierrez

    Recruiting

Other trials in Spain

Italy2 sites, 2 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

    Bologna

    Francesca Palandri, MD

    Not yet recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

    Francesco Passamonti, MD

    Not yet recruiting

Other trials in Italy

United Kingdom2 sites, 2 recruiting

  • Guy's Hospital

    London, UK

    Claire Harrison, MD, 07939059512

    Not yet recruiting

  • Genesis Cancer Care UK Limited - Oxford

    Oxford, UK

    Adam Mead, MD

    Not yet recruiting

Other trials in United Kingdom

France1 site, 1 recruiting

  • AP-HP Hopital Saint-Louis

    Paris

    Jean-Jacques Kiladjian

    Recruiting

Other trials in France

About this study

Official title: A Phase 1, Open-Label Study of LY5830966, a Type II JAK2 Inhibitor, in Patients With Myelofibrosis Previously Treated With a Type I JAK2 Inhibitor, JAK2 Inhibitor-Naïve Myelofibrosis, or High-risk Relapsed/Refractory Polycythemia Vera

J8G-MC-JDIA (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 Janus Kinase 2 (JAK2) inhibitor, LY5830966, in participants with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.

Read the detailed description

This is a phase 1, non-randomized, open-label study utilizing a 3+3 sequential dose escalation design followed by an expansion phase. The primary objective will be to evaluate the safety and tolerability of LY5830966 and establish a Maximally Tolerated Dose (MTD) and/or inform the establishment of a candidate Recommended Phase 3 dose (RP3D). The RP3D may be the maximally tolerated dose (MTD) or may be a dose below the MTD. The candidate RP3D will be based on adverse event (AE) pattern, pharmacokinetics (PK) and biomarker information, in addition to all available safety and efficacy data. Expansion cohorts will be enrolled to gather additional safety and efficacy information and to further refine input for future RP3D discussions. Eligible participants will have PMF, PPV-MF or PET-MF and will have either have relapsed after a response, or be refractory to, at least one prior type I JAK2 inhibitor therapy, either administered as monotherapy or in combination with another drug.

Being tested
LY5830966
Keywords
Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, PMF, PPV-MF, PET-MF
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY5830966Drug

    Also called AJ1-11095

    Type II JAK2 Inhibitor

Study groups in NCT06343805
Study groupRoleWhat they receive
Cohort 1ExperimentalDose A of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Cohort 2ExperimentalDose B of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Cohort 3ExperimentalDose C of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Cohort 4ExperimentalDose D of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Cohort 5ExperimentalDose E of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Dose Expansion Cohort 1ExperimentalCandidate RP3D of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Dose Expansion Cohort 2ExperimentalAlternative candidate RP3D of LY5830966 taken orally by participants.
Receives: Drug: LY5830966
Dose Exploration Cohort 1ExperimentalDose F of LY5830966 taken orally by participants
Receives: Drug: LY5830966
Dose Exploration Cohort 2ExperimentalDose G of LY5830966 taken orally by participants
Receives: Drug: LY5830966
Dose Exploration Cohort 3ExperimentalDose H of LY5830966 taken orally by participants[
Receives: Drug: LY5830966

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

    Measured: Baseline through study completion, an average of 1 year

  2. Number of patients with Dose Limiting Toxicities (DLTs)

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

    Measured: Baseline through study completion, an average of 1 year

  3. To establish the maximum tolerated dose (MTD) and/or recommended phase 3 dose (RP3D) of LY5830966

    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.

    Measured: Baseline through study completion, an average of 1 year

Secondary outcomes (8)

  1. To assess clinical response to LY5830966 evaluated by the Total Symptom Score (TSS).

    Number and proportion of patients with an improvement of ≥50% from Baseline in Total TSS as well as time to TSS response and duration of TSS response using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. The TSS is a 7 question assessment form with lower scores indicating better outcomes.

    Measured: Baseline through Week 24

  2. To assess clinical response to LY5830966 evaluated by spleen volume assessments.

    Spleen volume reduction (SVR) of ≥35% from Baseline measured by magnetic resonance imaging (MRI) or computed tomography (CT).

    Measured: Baseline through Week 24

  3. To assess clinical response to LY5830966 evaluated by spleen length assessments.

    Proportion of subjects with ≥50% reduction in length of spleen assessed by palpation.

    Measured: Baseline through Week 24

  4. To assess clinical response to LY5830966 evaluated through spleen size improvement.

    Time to spleen size improvement response measured by patient and across all patients.

    Measured: Baseline through Week 24

  5. To evaluate the Area Under the Curve (AUC) of LY5830966

    AUC time curve from 0 to 24 hrs post dose and percent difference between intervals will be evaluated.

    Measured: Pre dose and post dose Cycle 1 (Day 1, and Day 2 (24hrs post), and Cycle 2 (Day 1 and 24 hrs post).

  6. To evaluate the Cmax of LY5830966

    The maximum observed plasma concentration will be evaluated.

    Measured: Pre dose and post dose Cycle 1 (Day 1, and Day 2 (24hrs post), and Cycle 2 (Day 1 and 24 hrs post).

  7. To evaluate the Tmax of LY5830966

    The duration of time taken to reach Cmax will be evaluated.

    Measured: Pre dose and post dose Cycle 1 (Day 1, and Day 2 (24hrs post), and Cycle 2 (Day 1 and 24 hrs post).

  8. To evaluate the half-life of LY5830966

    The depletion of AJ1-00195 in the body will be observed over time.

    Measured: Pre dose and post dose Cycle 1 (Day 1, and Day 2 (24hrs post), and Cycle 2 (Day 1 and 24 hrs post).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start3 Oct 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This dose escalation study will follow a 3+3 cohort design until the RP3D and/or MTD is determined.
Masking
None (open label)
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06343805
Sponsor's protocol ID
27978
Other IDs
2025-522033-64-00, J8G-MC-JDIA, AJX-101, 2025
Status last verified
Oct 2026
First submitted
13 Mar 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY5830966 in people with Primary Myelofibrosis, run by Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Spain, Italy, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Steensma, M.D. (917-410-7250, david@ajaxtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Baseline through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06343805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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