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)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Ajax Therapeutics, Inc.
Study ID
NCT06343805
Phase
PHASE1
Status
Recruiting
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Conditions

  • PET-MF
  • PMF
  • PPV-MF
  • Post-Essential Thrombocythemia Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AJ1-11095 — DRUG
    Type II JAK2 Inhibitor

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
May 2026
Primary completion
Oct 15, 2026
Completion
Feb 15, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Dose A of AJ1-11095 taken orally by patients.
  • Experimental: Cohort 2
    Dose B of AJ1-11095 taken orally by patients.
  • Experimental: Cohort 3
    Dose C of AJ1-11095 taken orally by patients.
  • Experimental: Cohort 4
    Dose D of AJ1-11095 taken orally by patients.
  • Experimental: Cohort 5
    Dose E of AJ1-11095 taken orally by patients.
  • Experimental: Dose Expansion Cohort 1
    Candidate RP2D of AJ1-11095 taken orally by patients.
  • Experimental: Dose Expansion Cohort 2
    Alternative candidate RP2D of AJ1-11095 taken orally by patients.

Primary Outcome Measure

Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0. [ Time Frame: Baseline through study completion, an average of 1 year ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstitutePalo AltoCalifornia94304
William Shomali, MD
650-498-6000
Moffitt Cancer Cancer CenterTampaFlorida33612
Andrew Kuykendall, MD
813-745-4639
University of Kansas Medical CenterKansas CityKansas66160
Abdulraheem Yacoub, MD
Dana Farber Cancer InstituteBostonMassachusetts02115
Jacqueline Garcia, MD
617-632-1906
Massachusetts General HospitalBostonMassachusetts02114
Gabriela Hobbs, MD
617-724-1124
University of MichiganAnn ArborMichigan48109
Kristen Pettit, MD
734-647-2829
Washington University School of MedicineSt LouisMissouri63110
Stephen Oh, MD
314-362-8814
David H. Koch Center for Cancer Care at Memorial Sloan KetteringNew YorkNew York10021
Raajit Rampal, MD
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
John Mascarenhas, MD
212-241-8839
Levine Cancer InstituteCharlotteNorth Carolina28204
Michael Grunwald, MD
980-442-4363
University of CincinnatiCincinnatiOhio45221
Eric Vick, MD
513-213-3203
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Uma Borate, MD
614-685-9828
MD Anderson Cancer CenterHoustonTexas77030
Prithviraj Bose, MD
713-792-7747

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By research site
Stanford Cancer Institute· Palo Alto, CAMoffitt Cancer Cancer Center· Tampa, FLUniversity of Kansas Medical Center· Kansas City, KSDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MI

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