At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LY5830966 (drug)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- LY5830966 — drug: Type II JAK2 Inhibitor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 256
- Started
- 2024-10-03
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for primary myelofibrosis
- • Phase1 - 256 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with primary myelofibrosis
Where?
- • London - Guy's Hospital
- • Oxford - Genesis Cancer Care UK Limited - Oxford
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ at least 1 type I JAK2 inhibit
- ✓ including but not limited to interferon-based therapies
What the study is looking for
- ✓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...
- ✓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...
- ✓activity scale performance score (ECOG PS) of 0, 1, 2, or 3.
Who cannot take part
- ✗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...
- ✗Active, uncontrolled systemic infection or active Hepatitis B or C
- ✗drug treatment 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).
See the full criteria
Where Is This Study? (2 UK sites)
Guy's Hospital
London, United Kingdom
Genesis Cancer Care UK Limited - Oxford
Oxford, United Kingdom
How to Get in Touch
David Steensma, M.D.
Sponsor contactCONTACT
