Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT05782959
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '52 weeks', 'description': 'Includes complete response, very good partial response, partial response'}, {'measure': 'Duration of response', 'timeFrame': '52 weeks'}, {'measure': 'Time to response', 'timeFrame': '52 weeks'}, {'measure': 'Event-free survival', 'timeFrame': '52 weeks'}, {'measure': 'Overall survival', 'timeFrame': '52 weeks'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with adverse reactions', 'timeFrame': '52 weeks'}, {'measure': 'Proportion of subjects with serious adverse reactions', 'timeFrame': '52 weeks'}, {'measure': 'Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0', 'timeFrame': '52 weeks'}, {'measure': 'Proportion of therapy discontinuations due to adverse reactions', 'timeFrame': 'up to 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve from time zero to t (AUC 0-t)', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Area under the plasma concentration versus time curve from zero to time infinity (AUC 0-∞)', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Time of peak plasma concentration (Tmax)', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'up to 4 weeks', 'description': 'Half-life is the time taken to decrease the plasma concentration of a drug to one-half its original value'}, {'measure': 'Volume of distribution (Vd)', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Mean steady-state peak plasma concentration (Cmax)', 'timeFrame': '20 weeks'}, {'measure': 'Pre-dose trough concentration (Ctrough)', 'timeFrame': '20 weeks'}, {'measure': 'Counts of lymphocytes and CD56+CD16+ (cytokine-secreting and cytotoxic) NK cells', 'timeFrame': '52 weeks'}, {'measure': 'Whole blood cytolytic activity test', 'timeFrame': '52 weeks'}, {'measure': 'Proportion of subjects with anti-BCD-245 BAbs and NAbs', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory neuroblastoma.', 'detailedDescription': 'The study includes 2 stages: 1) Data collection and safety analysis for the first four subjects 12 years of age and older from Cohort 1 2) Data collection and analysis of safety, pharmacokinetics, pharmacodynamics and immunogenicity in all cohorts (Cohorts 1-4).\n\nThe design of this Phase I study is based on standard 3 + 3 design approaches. Cohort 1 includes 4 subjects aged 12 years old and older, and 2 subjects aged 3 years old and older. Cohorts 2-4 include 3-6 subjects aged 3 years and older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 3 years and older (12 years and older for the first four subjects) at the time of signing the informed consent form\n* Established diagnosis of neuroblastoma (confirmed by the study site laboratory where the subject will be treated) based on: a) histological examination of the tumor tissue (with or without immunohistochemistry) or b) presence of typical tumor agglomerates in the bone marrow and/or meta-iodobenzylguanidine-accumulating focus (foci) and an increase in the level of catecholamine metabolites in serum and/or urine\n* Relapsed or refractory neuroblastoma resistant to the anti-relapse therapy adopted at the study site\n* Satisfactory performance status (\\>70 on the Lansky or Karnofsky scale)\n* Life expectancy \\>8 weeks\n\nExclusion Criteria:\n\n* Indications for radiation therapy, surgical intervention for the primary disease at screening\n* Isolated CNS relapse of neuroblastoma\n* Planned use of any anticancer drugs concomitantly with BCD-245 in this clinical trial\n* The need for continuous use of anticonvulsants\n* Clinically significant neurological deficit or grade \\>2 peripheral neuropathy (CTCAE 5.0)\n* The need or probable need for systemic continuous use of glucocorticosteroids or other immunosuppressive drugs\n* Signs of respiratory distress (dyspnea at rest and oxygen saturation \\<94% without oxygen supplementation)\n* Any severe organ dysfunction (\\> CTCAE 5.0 severity grade 2) at screening, except for hematological abnormalities.\n* Body weight less than 10 kg.\n* Subject receiving anti-GD2 monoclonal antibody therapy within 6 weeks or less prior to intended study drug infusion'}, 'identificationModule': {'nctId': 'NCT05782959', 'briefTitle': 'Phase 1 Study of BCD-245 in Subjects With Neuroblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'An Open-Label, Dose-Escalation, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-245 (JSC BIOCAD, Russia) Administered Intravenously to Subjects With Neuroblastoma', 'orgStudyIdInfo': {'id': 'BCD-245-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'BCD-245 (anti-GD-2 monoclonal antibody), dose 1', 'interventionNames': ['Biological: BCD-245']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'BCD-245 (anti-GD-2 monoclonal antibody), dose 2', 'interventionNames': ['Biological: BCD-245']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'BCD-245 (anti-GD-2 monoclonal antibody), dose 3', 'interventionNames': ['Biological: BCD-245']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'BCD-245 (anti-GD-2 monoclonal antibody), dose 4', 'interventionNames': ['Biological: BCD-245']}], 'interventions': [{'name': 'BCD-245', 'type': 'BIOLOGICAL', 'description': 'BCD-245 is administered as prolonged intravenous infusions during each cycle', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mikhail A Maschan', 'role': 'CONTACT', 'email': 'info@fnkc.ru', 'phone': '+7 495 287 65 70'}], 'facility': 'Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Svetlana R Varfolomeev', 'role': 'CONTACT', 'email': 'info@ronc.ru', 'phone': '+7 (499) 324-24-24'}], 'facility': 'Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ludmila S Zubarovskaya', 'role': 'CONTACT', 'email': 'bmt-director@1spbgmu.ru', 'phone': '+7(812) 338 6265'}], 'facility': 'Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Maria Morozova', 'role': 'CONTACT', 'email': 'morozovama@biocad.ru', 'phone': '+7 (495) 992 66 28', 'phoneExt': '8436'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}