Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT02565758
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051677', 'term': 'Histiocytoma, Malignant Fibrous'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D051642', 'term': 'Histiocytoma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Terminal elimination half life of ABBV-085.', 'timeFrame': 'UP to 24 months'}, {'measure': 'Maximum observed plasma concentration (Cmax) of ABBV-085.', 'timeFrame': 'Up to 24 months'}, {'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Up to 24 months', 'description': 'Collect all adverse events at each visit.'}, {'measure': 'Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.', 'timeFrame': 'Up 24 months', 'description': 'AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 24 months', 'description': 'ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 24 months', 'description': 'PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first.'}, {'measure': 'Duration of overall response (DOR)', 'timeFrame': 'Up to 24 months', 'description': "DOR is defined as the time from the participant's initial CR or PR to the time of disease progression."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Advanced Solid Tumors', 'Neoplasm', 'Undifferentiated pleomorphic sarcoma', 'squamous cell carcinoma of the head and neck', 'carcinoma of the breast', 'antibody drug conjugate'], 'conditions': ['Advanced Solid Tumors', 'Undifferentiated Pleomorphic Sarcoma', 'Squamous Cell Carcinoma of the Head and Neck', 'Carcinoma of the Breast']}, 'referencesModule': {'references': [{'pmid': '35260879', 'type': 'DERIVED', 'citation': 'Ray U, Pathoulas CL, Thirusangu P, Purcell JW, Kannan N, Shridhar V. Exploiting LRRC15 as a Novel Therapeutic Target in Cancer. Cancer Res. 2022 May 3;82(9):1675-1681. doi: 10.1158/0008-5472.CAN-21-3734.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n3. Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens:\n\n \\- Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens \\>=2 x upper limit of normal (ULN).\n4. All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.\n5. Participant has adequate bone marrow, renal, hepatic and cardiac function.\n6. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.\n\nExclusion Criteria:\n\n1. Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.\n2. Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of ABBV-085.\n3. Unresolved adverse events \\>= Grade 2 from prior anticancer therapy, except for alopecia.\n4. Participant has ongoing hemolysis.\n5. Major surgery within \\<=28 days prior to the first dose of ABBV-085.\n6. Clinically significant uncontrolled condition(s).\n7. Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.'}, 'identificationModule': {'nctId': 'NCT02565758', 'briefTitle': 'ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'M15-394'}, 'secondaryIdInfos': [{'id': '2015-001645-84', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A4 (ABBV-085)', 'description': 'ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson', 'interventionNames': ['Drug: ABBV-085']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A3 (ABBV-085)', 'description': 'ABBV-085 will be administered at every cycle (28-day cycles).', 'interventionNames': ['Drug: ABBV-085']}], 'interventions': [{'name': 'ABBV-085', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion in 28-day dosing cycles.', 'armGroupLabels': ['Arm A3 (ABBV-085)', 'Arm A4 (ABBV-085)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona /ID# 148582', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258-4566', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare /ID# 151349', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles /ID# 148586', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ of Colorado Cancer Center /ID# 148581', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60637-1443', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago /ID# 148579', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute /ID# 143782', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 151348', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016-6402', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center /ID# 150786', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ Med Ctr /ID# 148200', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina BioOncology Institute /ID# 148583', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '19104-5502', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania /ID# 148576', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System /ID# 148652', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research /ID# 148580', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX, MD Anderson /ID# 147681', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics /ID# 141715', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists /ID# 148584', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Gustave Roussy /ID# 150300', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Univ Ramon y Cajal /ID# 150799', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Jimenez Diaz /ID# 148564', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hosp Univ Madrid Sanchinarro /ID# 146039', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}