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RECRUITING
NCT06343805
PHASE1

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)

Sponsor: Ajax Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-Label, Phase 1 Study of AJ1-11095 Administered as Oral Monotherapy 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2024-10-23

Completion Date

2027-02-15

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

AJ1-11095

Type II JAK2 Inhibitor

Locations (16)

Stanford Cancer Institute

Palo Alto, California, United States

Moffitt Cancer Cancer Center

Tampa, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

AP-HP Hopital Saint-Louis

Paris, France

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain