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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: Recruiting Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by Ajax Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment Emergent AEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability of AJ1-11095.
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 |
What NCT06343805 shows while recruiting
NCT06343805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 118-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (36% lower).
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 lists 15 locations in 11 states (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.
Learn More About Clinical Trials
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Where NCT06343805's enrollment target sits among peer trials
76 11th of 30 higher than 20 of 30 other Primary Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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