Myeloproliferative Neoplasms Clinical Trial

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)

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) and pharmacodynamics (PD) 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.

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Full Description

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 AJ1-11095, and establish a Maximally Tolerated Dose (MTD) and/or inform the establishment of a candidate Recommended Phase 2 dose (RP2D). The RP2D may be the maximally tolerated dose (MTD) or may be a dose below the MTD. The candidate RP2D will be based on AE pattern, 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 RP2D 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18 years of age or older.
Diagnosis of PMF, post-PV MF, or post-ET MF.
DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status.
Estimated spleen volume ≥450cm3.
MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.
ECOG PS of 0, 1, 2, or 3.
Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.
ANC ≥1.0×10^9/L.
Platelet count ≥75×10^9/L.
eGFR ≥45 mL/min/1.73m2.
Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
AST and ALT ≤3.0 × ULN.
QTcF ≤480 msec.

Exclusion Criteria:

Prior splenectomy.
Splenic irradiation within 3 months prior to first dose of study drug.
Ongoing use of systemic corticosteroids at dose equivalent to >10mg/day of prednisone.
Uncontrolled intercurrent illness such as an acute infection.
Chronic active or acute hepatitis B or C infection.
Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).
Use of a JAK2 inhibitor in the previous 10 days.
Use of erythropoiesis stimulating agents (unless stable for >8 weeks).
Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
Unable or unwilling to undergo CT or MRI for spleen size imaging.
Pregnant or breastfeeding.
Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

76

Study ID:

NCT06343805

Recruitment Status:

Not yet recruiting

Sponsor:

Ajax Therapeutics, Inc.

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There are 9 Locations for this study

See Locations Near You

Moffitt Cancer Cancer Center
Tampa Florida, 33612, United States More Info
Andrew Kuykendall, MD
Contact
813-745-4639
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Abdulraheem Yacoub, MD
Contact
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Gabriela Hobbs, MD
Contact
617-724-1124
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Jacqueline Garcia, MD
Contact
617-632-1906
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Stephen Oh, MD
Contact
314-362-8814
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
John Mascarenhas, MD
Contact
212-241-8839
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Michael Grunwald, MD
Contact
980-442-4363
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Uma Borate, MD
Contact
614-685-9828
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Prithviraj Bose, MD
Contact
713-792-7747

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

76

Study ID:

NCT06343805

Recruitment Status:

Not yet recruiting

Sponsor:


Ajax Therapeutics, Inc.

How clear is this clinincal trial information?

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