Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT06359002
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicities (dose escalation)', 'timeFrame': '21 days'}, {'measure': 'Composite Complete Remission Rate (expansion)', 'timeFrame': 'Up to 24 months', 'description': 'CR + CRh + CRi according ELN 2022 criteria'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events', 'timeFrame': 'Up to 24 months'}, {'measure': 'Number of patients with dose modifications', 'timeFrame': 'Up to 24 months'}, {'measure': 'Rate of early death', 'timeFrame': 'Within 3 treatment cycles'}, {'measure': 'Maximum Plasma Concentration (Cmax) BYON4413', 'timeFrame': 'Up to 24 months'}, {'measure': 'Time to Cmax (Tmax) BYON4413', 'timeFrame': 'Up to 24 months'}, {'measure': 'Area under the curve (AUC) BYON4413', 'timeFrame': 'Up to 24 months'}, {'measure': 'Percentage of patients with confirmed anti-BYON4413 antibodies', 'timeFrame': 'Up to 24 months'}, {'measure': 'Composite Complete Remission Rate (dose escalation)', 'timeFrame': 'Up to 24 months', 'description': 'CR + CRh + CRi according ELN 2022 criteria'}, {'measure': 'Percentage of blasts in bone marrow change from baseline', 'timeFrame': 'Up to 24 months'}, {'measure': 'Percentage of blasts in peripheral blood change from baseline', 'timeFrame': 'Up to 24 months'}, {'measure': 'Objective response rate', 'timeFrame': 'Up to 24 months', 'description': 'CR + CRh + CRi + MLFS + PR according ELN 2022 criteria'}, {'measure': 'Duration of response', 'timeFrame': 'Up to 24 months'}, {'measure': 'Relapse-free survival', 'timeFrame': 'Up to 24 months'}, {'measure': 'Event-free survival', 'timeFrame': 'Up to 24 months'}, {'measure': 'Time to response', 'timeFrame': 'Up to 24 months'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BYON4413', 'CD123', 'Hematologic Malignancies', 'Antibody Drug Conjugate', 'AML', 'MDS'], 'conditions': ['Relapsed / Refractory AML', 'Relapsed / Refractory MDS']}, 'descriptionModule': {'briefSummary': 'This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.', 'detailedDescription': 'This trial includes two parts. Part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of BYON4413 will be determined. Part 2 is an expansion study to evaluate the anti-leukemia activity and safety of BYON4413.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of:\n\n * R/R AML (WHO 2022) OR\n * MDS (WHO 2022) with ≥10% blasts in BM and have received ≥3 cycles of HMA\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;\n* Adequate baseline organ function.\n\nExclusion Criteria:\n\n* Having been treated with any CD123-targeting therapies;\n* Having received allogeneic hematopoietic stem cell transplantation within 100 days prior to start Cycle 1 Day 1;\n* Having treatment-related toxicities from prior anti-leukemia therapies that have not resolved to CTCAE Grade ≤ 1;\n* Having active central nervous system AML or AML of the APL/M3 subtype;\n* History of keratitis;\n* History of specified lung or renal disease;\n* Having clinically significant cardiovascular disease;\n* Known infection of Hepatitis B, C or E.\n\nKey inclusion and exclusion criteria details are listed here, additional requirements may apply.'}, 'identificationModule': {'nctId': 'NCT06359002', 'briefTitle': 'Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Byondis B.V.'}, 'officialTitle': 'A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.', 'orgStudyIdInfo': {'id': 'BYON4413.001'}, 'secondaryIdInfos': [{'id': '2023-507781-13-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'Escalating dose cohorts of BYON4413 for patients with AML or MDS.', 'interventionNames': ['Drug: BYON4413']}], 'interventions': [{'name': 'BYON4413', 'type': 'DRUG', 'description': 'BYON4413 will be administered by IV infusion.', 'armGroupLabels': ['Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dimitri Breems', 'role': 'CONTACT'}], 'facility': 'Het Ziekenhuisnetwerk Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Johan Maertens', 'role': 'CONTACT'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Saskia Karina Klein', 'role': 'CONTACT'}], 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Badalona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Susana Vives Polo', 'role': 'CONTACT'}], 'facility': "Institut Catala d'Oncologia", 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jordi Esteve Reyner', 'role': 'CONTACT'}], 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Garrido Diaz', 'role': 'CONTACT'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cáceres', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Miguel Bergua Burgues', 'role': 'CONTACT'}], 'facility': 'Hospital San Pedro de Alcantara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Diez Campelo', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pau Montesinos', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario y Politecnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Glenn van Wigcheren', 'role': 'CONTACT', 'email': 'clinicaltrials@byondis.com', 'phone': '+31 24 679 5100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Byondis B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}