Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT05005403
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2021-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C537768', 'term': 'Anophthalmia with pulmonary hypoplasia'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719868', 'term': 'budigalimab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 512}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2021-08-12', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AE)', 'timeFrame': 'Up to 2 Years', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of ABBV-514', 'timeFrame': 'Up to 2 Years', 'description': 'Maximum Observed Serum Concentration (Cmax) of of ABBV-514.'}, {'measure': 'Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514', 'timeFrame': 'Up to 2 Years', 'description': 'Time to maximum Observed Serum Concentration (Tmax) of of ABBV-514.'}, {'measure': 'Terminal Elimination Half-Life (t1/2) of ABBV-514', 'timeFrame': 'Up to 2 Years', 'description': 'Terminal elimination half-life (t1/2) of ABBV-514.'}, {'measure': 'Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514', 'timeFrame': 'Up to 2 Years', 'description': 'Area under the serum concentration versus time curve (AUC) of ABBV-514.'}, {'measure': 'Antidrug Antibody (ADA)', 'timeFrame': 'Up to 2 Years', 'description': 'Incidence and concentration of anti-drug antibodies.'}, {'measure': 'Neutralizing Antidrug Antibody (nADA)', 'timeFrame': 'Up to 2 Years', 'description': 'Incidence and concentration of neutralizing anti-drug antibodies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer', 'NSCLC', 'Head and Neck Squamous Cell Carcinoma', 'HNSCC', 'Solid Tumors', 'Budigalimab', 'ABBV-181', 'ABBV-514', 'Micro Satellite Stable Colorectal Cancer', 'MSS-CRC, Gastric Cancer', 'Esophageal Cancer', 'GEA', 'GEJ', 'High-Grade Serous Ovarian Cancer', 'HGSOC', 'Pancreatic Cancer, PDAC', 'Triple Negative Breast Cancer', 'TNBC'], 'conditions': ['Non-Small Cell Lung Cancer', 'Head and Neck Squamous Cell Carcinoma', 'Micro Satellite Stable Colorectal Cancer', 'Gastric/Esophageal Cancer', 'High-Grade Serous Ovarian Cancer', 'Pancreatic Cancer', 'Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of Azirkitug (ABBV-514) as a monotherapy and in combination with Budigalimab or Bevacizumab,.\n\nBevacizumab is an approved product, while Budigalimab and Azirkitug (ABBV-514) are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of Azirkitug (ABBV-514) will be explored. Each treatment arm receives a different dose of Azirkitug (ABBV-514) in monotherapy and in combination with Budigalimab or Bevacizumab. Approximately 512 adult participants will be enrolled in the study across approximately 80 sites worldwide.\n\nParticipants will receive Azirkitug (ABBV-514) as a monotherapy or in combination with Budigalimab or Bevacizumab as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of \\<=1\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Laboratory values meeting criteria outlined in the protocol\n* NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.\n* HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.\n* Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib and not MSI-h or MMR-deficient\n* Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and/or HER2 therapy\n* High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \\>5 lines of prior therapy.\n* Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.\n* Triple Negative Breast Cancer (TNBC) - Progressed after \\>1 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation\n\nExclusion Criteria:\n\n* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE\n* No major surgery within 28 days prior to dosing\n* No active autoimmune/immunodeficiency disease with limited exceptions\n* Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events\n* Pregnancy\n* Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions'}, 'identificationModule': {'nctId': 'NCT05005403', 'briefTitle': 'Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With Azirkitug (ABBV-514) as a Single Agent and in Combination With Budigalimab or Bevacizumab', 'orgStudyIdInfo': {'id': 'M21-410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation: Azirkitug (ABBV-514)', 'description': 'Participants will receive Azirkitug (ABBV-514).', 'interventionNames': ['Drug: Azirkitug']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Expansion: Azirkitug (ABBV-514)', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.', 'interventionNames': ['Drug: Azirkitug']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4 Dose Expansion: Azirkitug (ABBV-514)', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.', 'interventionNames': ['Drug: Azirkitug']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 5 Dose Expansion: Azirkitug (ABBV-514)', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.', 'interventionNames': ['Drug: Azirkitug']}, {'type': 'EXPERIMENTAL', 'label': 'Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab', 'description': 'Participants will receive Azirkitug (ABBV-514) in combination with bevacizumab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with bevacizumab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'description': 'Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.', 'interventionNames': ['Drug: Azirkitug', 'Drug: Budigalimab']}], 'interventions': [{'name': 'Azirkitug', 'type': 'DRUG', 'otherNames': ['ABBV-514'], 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Part 1 Dose Escalation: Azirkitug (ABBV-514)', 'Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab', 'Part 2 Dose Expansion: Azirkitug (ABBV-514)', 'Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 4 Dose Expansion: Azirkitug (ABBV-514)', 'Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 5 Dose Expansion: Azirkitug (ABBV-514)', 'Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab', 'Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab', 'Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab']}, {'name': 'Budigalimab', 'type': 'DRUG', 'otherNames': ['ABBV-181'], 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab', 'Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab', 'Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab', 'Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope National Medical Center /ID# 276272', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Illinois Hospital and Health Sciences System /ID# 251750', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46250-2042', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Health Network, Inc. /ID# 243011', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40241-2832', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norton Cancer Institute /ID# 248903', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '49546-7062', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START Midwest /ID# 248685', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '844-663-3742'}], 'facility': 'Carolina BioOncology Institute /ID# 232597', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '78705-1171', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology Austin /ID# 243005', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center /ID# 270059', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology /ID# 243007', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics (START) /ID# 276268', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84119', 'city': 'West Valley City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Start Mountain Region /ID# 276270', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virginia Cancer Specialists - Fairfax /ID# 232592', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center /ID# 238332', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '3109601', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Rambam Health Care Campus /ID# 238333', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Hadassah Medical Center-Hebrew University /ID# 252287', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4941492', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Rabin Medical Center /ID# 250497', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital /ID# 250405', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East /ID# 238840'}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kobe University Hospital /ID# 250409', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '573-1191', 'city': 'Hirakata-shi', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kansai Medical University Hospital /ID# 276805'}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center /ID# 250408'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Cancer Center Hospital /ID# 238372'}, {'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Wakayama Medical University Hospital /ID# 276806', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'National Cancer Center /ID# 252290', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '13496', 'city': 'Seongnam', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center /ID# 252291', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Yonsei University Health System Severance Hospital /ID# 252288', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center /ID# 252289', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '100', 'city': 'Taipei City', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital /ID# 251894'}, {'zip': '23561', 'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Taipei Medical University Shuang Ho Hospital /ID# 252449', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '704', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital /ID# 252262', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '11031', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital /ID# 252450', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11490', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital /ID# 252263', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}