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NCT06343805 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of AJ1-11095 in Patients 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 of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by Ajax Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 15
- Study locations
NCT06343805 is a Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis that is actively recruiting participants, run by Ajax Therapeutics. The registered enrollment target is 76 participants, below the 118-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (36% lower). The trial reports 15 study locations across 11 states.
The verdict
NCT06343805, a Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, is actively recruiting participants, sponsored by Ajax Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 15
- Study locations
Study Summary
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 JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.
Conditions Studied
Interventions
- DRUG AJ1-11095
Study Locations (15)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering - New York
- Icahn School of Medicine at Mount Sinai - New York
Ohio
- University of Cincinnati - Cincinnati
- The Ohio State University Comprehensive Cancer Center - Columbus
Other
- AP-HP Hopital Saint-Louis - Paris
- Hospital Clinic Barcelona - Barcelona
California
- Stanford Cancer Institute - Palo Alto
Florida
- Moffitt Cancer Cancer Center - Tampa
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2024-10-23 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06343805
The ClinicalTrials.gov registry entry for NCT06343805 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (36% lower). The listed sponsor is Ajax Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 1 intervention - of which AJ1-11095 is the first listed.
NCT06343805 reports 15 study locations spanning 11 distinct geographic areas - top geographies include Massachusetts, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT06343805 about?
NCT06343805 is a clinical study titled "A Phase 1 Study of AJ1-11095 in Patients 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)". 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 JAK2 inhibitor, AJ1-11095, in subjects with prima...
What is the current status of trial NCT06343805?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2024-10-23. Estimated completion is 2027-02-15.
What conditions does trial NCT06343805 study?
This clinical trial studies the following conditions: Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, PMF, PPV-MF.
What interventions are being tested in trial NCT06343805?
The interventions under investigation include: AJ1-11095 (DRUG).
Who is sponsoring clinical trial NCT06343805?
This trial is sponsored by Ajax Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06343805 being conducted?
This trial has 15 study locations across California, Florida, Kansas, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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