Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 9:09 PM
Study NCT ID:
NCT05692050
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2023-02-03
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Epcoritamab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Expanded Access', 'Pre-approval Access', 'Compassionate Use', 'Special Access Program', 'Named Patient Basis', 'Special Access Scheme'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to epcoritamab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The participant must not be eligible for an epcoritamab clinical trial.'}, 'identificationModule': {'nctId': 'NCT05692050', 'briefTitle': 'Expanded Access to Epcoritamab', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Expanded Access to Epcoritamab', 'orgStudyIdInfo': {'id': 'C23-496'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epcoritamab', 'type': 'DRUG', 'otherNames': ['ABBV-GMAB-3013'], 'description': 'Subcutaneous Injection'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genmab', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}