Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-01-09 @ 6:19 PM
Study NCT ID:
NCT06533761
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2024-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0', 'timeFrame': '12 months'}, {'measure': 'Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1', 'timeFrame': '28-35 days'}, {'measure': 'Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration time curve extrapolated to the last measurable time point [AUClast] of eganelisib and cytarabine', 'timeFrame': '112 days'}, {'measure': 'Maximum concentration [Cmax] of eganelisib and cytarabine', 'timeFrame': '112 days'}, {'measure': 'Time of maximum concentration [Tmax] of eganelisib and cytarabine', 'timeFrame': '112 days'}, {'measure': 'Plasma half-life [t1/2] of eganelisib and cytarabine', 'timeFrame': '112 days'}, {'measure': 'Measure plasma concentrations of eganelisib and determine model-based PK parameters', 'timeFrame': '112 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AML, Adult', 'MDS']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS).\n\nThe study consists of 2 parts:\n\n* Part 1: Dose Escalation (DE) in both monotherapy and in combination.\n* Part 2: Dose Optimization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.\n* Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).\n* Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \\>72 hours prior to treatment\n* WBC count \\>25 × 10\\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).\n* Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.'}, 'identificationModule': {'nctId': 'NCT06533761', 'briefTitle': 'Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stelexis BioSciences'}, 'officialTitle': 'A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'STLX-EGA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eganelisib', 'interventionNames': ['Drug: Eganelisib']}, {'type': 'EXPERIMENTAL', 'label': 'Eganelisib in combination with cytarabine', 'interventionNames': ['Drug: Eganelisib in combination with cytarabine']}], 'interventions': [{'name': 'Eganelisib', 'type': 'DRUG', 'description': 'eganelisib will be administered as monotherapy', 'armGroupLabels': ['Eganelisib']}, {'name': 'Eganelisib in combination with cytarabine', 'type': 'DRUG', 'description': 'eganelisib will be administered in combination with cytarabine', 'armGroupLabels': ['Eganelisib in combination with cytarabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shukaib Arslan', 'role': 'CONTACT', 'email': 'sarslan@coh.org', 'phone': '626-218-1133'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kara Grau', 'role': 'CONTACT', 'email': 'kara.grau@cuanschutz.edu'}], 'facility': 'Anshutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wes Mungal', 'role': 'CONTACT', 'email': 'Wesley.Mungal@moffitt.org', 'phone': '813-745-0851'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Forsyth', 'role': 'CONTACT', 'email': 'Megan_Forsyth@DFCI.Harvard.edu', 'phone': '857-215-1405'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Na'kie Coleman-Elhasan", 'role': 'CONTACT', 'email': 'nakie@wustl.edu', 'phone': '314-454-8708'}], 'facility': 'Washington University in St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anmol Shah', 'role': 'CONTACT', 'email': 'shaha10@mskcc.org', 'phone': '646-608-2813'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anmol Shah', 'role': 'CONTACT', 'email': 'shaha10@mskcc.org', 'phone': '646-608-2813'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10466', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Davina Hoban', 'role': 'CONTACT', 'email': 'davinahoban@montefiore.org', 'phone': '201-618-4725'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ibraheem Al-Aref', 'role': 'CONTACT', 'email': 'ali3@ccf.org', 'phone': '216-442-0461'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Mayne', 'role': 'CONTACT', 'email': 'sarah.mayne@osumc.edu', 'phone': '614-685-9573'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meagan Sachs', 'role': 'CONTACT', 'email': 'msachs@mdanderson.org', 'phone': '713-503-1589'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '10003', 'city': 'Cáceres', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Miguel Bergua Burgues', 'role': 'CONTACT', 'email': 'jmberguaburg@gmail.com', 'phone': '+34 675 699735'}], 'facility': 'Hospital San Pedro de Alcántara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rebeca Rodriguez Veiga', 'role': 'CONTACT', 'email': 'rebeca_rodriguez@iislafe.es', 'phone': '+34 961 245876'}], 'facility': 'Hospital Universitari i Politècnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Clinical Trials Office Stelexis', 'role': 'CONTACT', 'email': 'clinicaltrials@stelexis.com', 'phone': '508-543-6979'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stelexis BioSciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}