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