Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 11:50 PM
Study NCT ID:
NCT01255657
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ABT-806 in Subjects With Advanced Solid Tumor Types
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604456', 'term': 'depatuxizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Number of subjects with adverse events and/or dose-limiting toxicities)', 'timeFrame': 'At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)', 'description': 'Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)'}, {'measure': 'Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort', 'timeFrame': 'Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit', 'description': 'Assay for ABT-806'}, {'measure': 'Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort', 'timeFrame': 'Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up', 'description': 'Assay for ABT-806'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort', 'timeFrame': 'Week 1, 3, 7, 11, 15, 19, 23 and Final Visit', 'description': 'Assay for Anti-drug antibody against ABT-806'}, {'measure': 'QT assessment', 'timeFrame': 'Week 1, 7, 13, and 30 day follow-up visit', 'description': 'Triplicate ECGs'}, {'measure': 'Infusion rate evaluation (Expanded Safety Cohort)', 'timeFrame': 'Every other week', 'description': 'Two infusion times explored'}, {'measure': 'Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort', 'timeFrame': 'Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up', 'description': 'Assay for Anti-drug antibody against ABT-806'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '25761639', 'type': 'RESULT', 'citation': 'Sharma S, Mittapalli RK, Holen KD, Xiong H. Population Pharmacokinetics of ABT-806, an Investigational Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody, in Advanced Solid Tumor Types Likely to Either Over-Express Wild-Type EGFR or Express Variant III Mutant EGFR. Clin Pharmacokinet. 2015 Oct;54(10):1071-81. doi: 10.1007/s40262-015-0258-2.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.\n* Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.\n* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n* Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\n* Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .\n\nExclusion Criteria:\n\n* Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.\n* Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.\n* Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.\n* Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.\n* Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.'}, 'identificationModule': {'nctId': 'NCT01255657', 'briefTitle': 'A Study of ABT-806 in Subjects With Advanced Solid Tumor Types', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR', 'orgStudyIdInfo': {'id': 'M11-847'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABT-806 Arm', 'interventionNames': ['Drug: ABT-806']}], 'interventions': [{'name': 'ABT-806', 'type': 'DRUG', 'description': 'ABT-806 will be administered by intravenous infusion.', 'armGroupLabels': ['ABT-806 Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 54056', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 41931', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 43422', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Kyle D. Holen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}