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Clinical Trials in the USA / NCT06343805
Recruiting Phase 1

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)

NCT06343805 · tracked via the Priya Life Science USA tracker
Sponsor
Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Phase
Phase 1
Started
2024-10-23
Last updated
2026-09-17

Condition(s) studied

Primary Myelofibrosis

Investigational drug(s) / intervention(s)

LY5830966

LY5830966: Type II JAK2 Inhibitor

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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%.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Stanford Cancer Institute Palo Alto California Recruiting
Moffitt Cancer Cancer Center Tampa Florida Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering New York New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Levine Cancer Institute Charlotte North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
AP-HP Hopital Saint-Louis Paris France Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola Bologna Italy Not Yet Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Not Yet Recruiting
Hospital General Universitario Gregorio Maranon Madrid Spain Recruiting
Hospital Clinic Barcelona Barcelona Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Guy's Hospital London UK Not Yet Recruiting
Genesis Cancer Care UK Limited - Oxford Oxford UK Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06343805 on ClinicalTrials.gov ↗ ← All trials in the USA