nctId: NCT06343805 id: AJX-101 briefTitle: 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) overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2026-08-15 date: 2027-02-15 date: 2024-04-03 date: 2024-04-18 name: Ajax Therapeutics, Inc. class: INDUSTRY briefSummary: 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. conditions: Primary Myelofibrosis conditions: Post-Essential Thrombocythemia Myelofibrosis conditions: Post-Polycythemia Vera Myelofibrosis conditions: PMF conditions: PPV-MF conditions: PET-MF studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This dose escalation study will follow a 3+3 cohort design until the RP2D and/or MTD is determined. primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: AJ1-11095 measure: Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0. measure: Number of patients with Dose Limiting Toxicities (DLTs) measure: To establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AJ1-11095 measure: To assess clinical response to AJ1-11095 evaluated by the Total Symptom Score (TSS). measure: To assess clinical response to AJ1-11095 evaluated by spleen volume assessments. measure: To assess clinical response to AJ1-11095 evaluated by spleen length assessments. measure: To assess clinical response to AJ1-11095 evaluated through spleen size improvement. measure: To evaluate the Area Under the Curve (AUC) of AJ1-11095 measure: To evaluate the Cmax of AJ1-11095 measure: To evaluate the Tmax of AJ1-11095 measure: To evaluate the half-life of AJ1-11095 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Cancer Center city: Tampa state: Florida zip: 33612 country: United States name: Andrew Kuykendall, MD role: CONTACT phone: 813-745-4639 email: Andrew.Kuykendall@moffitt.org lat: 27.94752 lon: -82.45843 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Abdulraheem Yacoub, MD role: CONTACT email: ayacoub@kumc.edu lat: 39.11417 lon: -94.62746 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Gabriela Hobbs, MD role: CONTACT phone: 617-724-1124 email: ghobbs@partners.org lat: 42.35843 lon: -71.05977 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02115 country: United States name: Jacqueline Garcia, MD role: CONTACT phone: 617-632-1906 email: jacqueline_garcia@dfci.harvard.edu lat: 42.35843 lon: -71.05977 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Stephen Oh, MD role: CONTACT phone: 314-362-8814 email: stoh@wustl.edu lat: 38.62727 lon: -90.19789 facility: Icahn School of Medicine at Mount Sinai city: New York state: New York zip: 10029 country: United States name: John Mascarenhas, MD role: CONTACT phone: 212-241-8839 email: john.mascarenhas@mssm.edu lat: 40.71427 lon: -74.00597 facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Michael Grunwald, MD role: CONTACT phone: 980-442-4363 email: michael.grunwald@atriumhealth.org lat: 35.22709 lon: -80.84313 facility: The Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Uma Borate, MD role: CONTACT phone: 614-685-9828 email: uma.borate@osumc.edu lat: 39.96118 lon: -82.99879 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Prithviraj Bose, MD role: CONTACT phone: 713-792-7747 email: PBose@mdanderson.org lat: 29.76328 lon: -95.36327 hasResults: False