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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- 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 LY5830966 — Baseline 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.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Clinic Barcelona | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Maranon | Madrid | 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 |
Other trials for the same condition
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 UK