Recruiting
Phase 1

AJ1-11095

Sponsor:

Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Code:

NCT06343805

Conditions

Primary Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY5830966

Study Details

Brief 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 participants with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.

Conditions

Primary Myelofibrosis

Study ID

NCT06343805

Start date

Oct 3, 2024

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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

Exclusion Criteria:

  • 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.

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%.

Study Design

Enrollment

256 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Dose A of LY5830966 taken orally by participants.

experimental: Cohort 2

Dose B of LY5830966 taken orally by participants.

experimental: Cohort 3

Dose C of LY5830966 taken orally by participants.

experimental: Cohort 4

Dose D of LY5830966 taken orally by participants.

experimental: Cohort 5

Dose E of LY5830966 taken orally by participants.

experimental: Dose Expansion Cohort 1

Candidate RP3D of LY5830966 taken orally by participants.

experimental: Dose Expansion Cohort 2

Alternative candidate RP3D of LY5830966 taken orally by participants.

experimental: Dose Exploration Cohort 1

Dose F of LY5830966 taken orally by participants

experimental: Dose Exploration Cohort 2

Dose G of LY5830966 taken orally by participants

experimental: Dose Exploration Cohort 3

Dose H of LY5830966 taken orally by participants\[

Interventions

LY5830966

Type II JAK2 Inhibitor

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 ]
  • Number of patients with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through study completion, an average of 1 year ]
  • To establish the maximum tolerated dose (MTD) and/or recommended phase 3 dose (RP3D) of LY5830966 [ Time Frame: Baseline through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

David Steensma, M.D.

917-410-7250david@ajaxtherapeutics.com

Locations

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304

Contacts

William Shomali, MD

650-498-6000

Moffitt Cancer Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Andrew Kuykendall, MD

813-745-4639

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Gabriela Hobbs, MD

617-724-1124

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jacqueline Garcia, MD

617-632-1906

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kristen Pettit, MD

734-647-2829

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stephen Oh, MD

314-362-8814

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

Recruiting

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

John Mascarenhas, MD

212-241-8839

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Michael Grunwald, MD

980-442-4363

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

Contacts

Eric Vick, MD

513-213-3203

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Uma Borate, MD

614-685-9828

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Prithviraj Bose, MD

713-792-7747

More Information

Sponsor

Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Post-Essential Thrombocythemia Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • PMF
  • PPV-MF
  • PET-MF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.