Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 9:30 AM
Study NCT ID:
NCT05119257
Status:
AVAILABLE
Last Update Posted:
2024-05-08
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(Bispecific) Antibodies in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018033', 'term': 'Antibodies, Bispecific'}], 'ancestors': [{'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True, 'intermediate': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-30', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.medizin.uni-tuebingen.de/de/das-klinikum/einrichtungen/kliniken/medizinische-klinik/kke-translationale-immunologie', 'label': 'CCU Translational Immunology'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to provide (bispecific) antibodies to individual patients with advanced solid and hematological malignancies without any available approved treatment options.', 'detailedDescription': 'Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG (German law).\n\nAll (bispecific antibodies) applied are developed and manufactured by the principle investigator Prof. Helmut Salih.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of advanced malignant disease\n* Advanced malignant disease without any available standard of care treatment option\n* Live expectancy \\> 3 month\n* Ability to understand and voluntarily sign an informed consent form.\n* Ability to adhere to the visit schedule and other protocol requirements\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.\n\nExclusion Criteria:\n\n* Pregnant or lactating females.\n* Treatment regimens inducing severe T cell deficiencies\n* Treatment-related side effect from prior cancer treatment \\> CTC grade 2 (CTCAE V5.0)\n* Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to Ab treatment.'}, 'identificationModule': {'nctId': 'NCT05119257', 'acronym': 'InHeAb01', 'briefTitle': '(Bispecific) Antibodies in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': '(Bispecific) Antibodies in Cancer Patients (InHeAb01)', 'orgStudyIdInfo': {'id': 'InHeAb01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bispecific antibodies (bsAB)', 'type': 'BIOLOGICAL', 'description': 'BsAbs equipped with a target-specificity directed to a TAA and an effector-specificity for an activating receptor on T cells, such as CD3 or CD28, are applied intravenously in repeated cycles until disease progression or dose limiting toxicity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'AVAILABLE', 'country': 'Germany', 'contacts': [{'name': 'Helmut R Salih, Prof.', 'role': 'CONTACT', 'email': 'helmut.salih@med.uni-tueningen.de', 'phone': '+49(0)707129', 'phoneExt': '83275'}, {'name': 'Juliane walz, Prof.', 'role': 'CONTACT', 'email': 'julian.walz@med.uni-tuebingen.de', 'phone': '+49(0)707129', 'phoneExt': '68746'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Helmut R. Salih, Prof.', 'role': 'CONTACT', 'email': 'helmut.salih@med.uni-tuebingen.de', 'phone': '+497071/2983275'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of CCU Translational Immunology (Developer and Manufacturer of applied bispecific antibodies)', 'investigatorFullName': 'Prof. Dr. Helmut Salih', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}