Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT00702494
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2008-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C569915', 'term': 'TB-403'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of an anti-PlGF antibody', 'timeFrame': '85 days'}], 'secondaryOutcomes': [{'measure': 'Determine multiple dose IV pharmacokinetics', 'timeFrame': '85 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['placental growth factor', 'monoclonal antibody', 'Phase I', 'solid tumors', 'Patients with solid tumors'], 'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': "TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.\n\nIn this study we are investigating the tolerability and safety of TB-403 in patients with solid tumors who receives multiple intravenous doses of TB-403."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed malignity\n* Measurable disease\n* Performance status 1 or less (ECOG)\n\nExclusion Criteria:\n\n* Acute illness or infection\n* Concurrent second malignancy'}, 'identificationModule': {'nctId': 'NCT00702494', 'briefTitle': 'Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioInvent International AB'}, 'officialTitle': 'An Open, Phase I, Dose Escalation Study of the Monoclonal Antibody TB-403 Directed Against PlGF, Given as Multiple IV-doses to Patients With Solid Tumors.', 'orgStudyIdInfo': {'id': '07-TB-403-02'}, 'secondaryIdInfos': [{'id': 'EUDRACT No: 2008-001345-25'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Multiple IV doses of TB-403, an antibody directed against PlGF', 'interventionNames': ['Biological: TB-403']}], 'interventions': [{'name': 'TB-403', 'type': 'BIOLOGICAL', 'description': 'Multiple IV', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Onkologisk Klinik 5072 Finsencentret Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'DK-2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Onkologisk Afdeling 54B1 Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Ulrik Lassen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Lena Winstedt, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioInvent International AB'}, {'name': 'Dorthe Nielsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital, Herlev, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioInvent International AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Oxurion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}