Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 9:06 AM
Study NCT ID:
NCT02988960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2016-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors
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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], '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': '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': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719868', 'term': 'budigalimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181', 'timeFrame': 'Up to 8 weeks', 'description': 'The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.'}, {'measure': 'Time to Cmax (Tmax) of ABBV-927', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Time to Cmax (Tmax) of ABBV-927.'}, {'measure': 'Maximum observed serum concentration (Cmax) of ABBV-927', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Maximum observed serum concentration (Cmax) of ABBV-927.'}, {'measure': 'Terminal-Phase Elimination Rate Constant (β) of ABBV-927', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Terminal-phase elimination rate constant (β)of ABBV-927.'}, {'measure': 'Terminal half-life (t1/2) of ABBV-927', 'timeFrame': "Up to 4 weeks after participant's first dose", 'description': 'Terminal half-life (t1/2) of ABBV-927.'}, {'measure': 'Area under the serum concentration-time curve (AUCt) of ABBV-927', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.'}, {'measure': 'Time to Cmax (Tmax) of ABBV-181', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Time to Cmax (Tmax) of ABBV-181.'}, {'measure': 'Maximum observed serum concentration (Cmax) of ABBV-181', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Maximum observed serum concentration (Cmax) of ABBV-181.'}, {'measure': 'Terminal-Phase Elimination Rate Constant (β) of ABBV-181', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Terminal-phase elimination rate constant (β)of ABBV-181.'}, {'measure': 'Terminal half-life (t1/2) of ABBV-181', 'timeFrame': "Up to 4 weeks after participant's first dose", 'description': 'Terminal half-life (t1/2) of ABBV-181.'}, {'measure': 'Area under the serum concentration-time curve (AUCt) of ABBV-181', 'timeFrame': "Up to 12 weeks after participant's first dose", 'description': 'Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to 30 days after and up to 24-month of treatment period', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)', 'timeFrame': 'Up to 30 days after and up to 24-month of treatment period', 'description': 'CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.'}, {'measure': 'Duration of objective response (DOR)', 'timeFrame': 'Up to 30 days after and up to 24-month of treatment period', 'description': 'DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 30 days after and up to 24-month of treatment period', 'description': 'ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 30 days after and up to 24-month of treatment period', 'description': 'PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer (NSCLC)', 'Squamous cell carcinoma of the head and neck (SCCHN)', 'Advanced solid tumor', 'Cancer', 'Pancreatic adenocarcinoma', 'Cutaneous melanoma', 'ABBV-927', 'ABBV-181', 'Budigalimab'], 'conditions': ['Advanced Solid Tumors Cancer']}, 'descriptionModule': {'briefSummary': 'This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n* Participants have adequate bone marrow, kidney and liver function.\n* Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram or multigated acquisition scan indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug.\n* Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.\n* Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN.\n* Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.\n* Participants in all combination therapy arms must have recurrent or metastatic HNSCC or NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must have received only one prior immunotherapy.\n* The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered.\n\nExclusion Criteria:\n\n* Participant must not have an active or prior documented autoimmune disease in the last 2 years.\n* Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).\n* Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung disease, or immune-mediated pneumonitis.\n* Participant must not have a history of clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation.\n* Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment.\n* Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.\n* Participant must not have a known uncontrolled malignancy of the central nervous system.\n* Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy.\n* Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.\n* Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.\n* Participant is judged by the investigator to have evidence of hemolysis.\n* For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).'}, 'identificationModule': {'nctId': 'NCT02988960', 'briefTitle': 'A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'M15-862'}, 'secondaryIdInfos': [{'id': '2016-002219-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Escalating Arm 1: ABBV-927', 'description': 'Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.', 'interventionNames': ['Drug: ABBV-927']}, {'type': 'EXPERIMENTAL', 'label': 'Escalating Arm 2: ABBV-927', 'description': 'Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.', 'interventionNames': ['Drug: ABBV-927']}, {'type': 'EXPERIMENTAL', 'label': 'Escalating Arm 3: ABBV-927+ABBV-181', 'description': 'Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.', 'interventionNames': ['Drug: ABBV-927', 'Drug: ABBV-181']}, {'type': 'EXPERIMENTAL', 'label': 'Escalating Arm 4: ABBV-927+ABBV-181', 'description': 'Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.', 'interventionNames': ['Drug: ABBV-927', 'Drug: ABBV-181']}, {'type': 'EXPERIMENTAL', 'label': 'Escalating Arm 5 (Japan): ABBV-927', 'description': 'Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.', 'interventionNames': ['Drug: ABBV-927']}, {'type': 'EXPERIMENTAL', 'label': 'Escalating Arm 6 (Japan): ABBV-927+ABBV-181', 'description': 'Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.', 'interventionNames': ['Drug: ABBV-927', 'Drug: ABBV-181']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm A: ABBV-927', 'description': 'Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.', 'interventionNames': ['Drug: ABBV-927']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm B: ABBV-927+ABBV-181', 'description': 'Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.', 'interventionNames': ['Drug: ABBV-927', 'Drug: ABBV-181']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm C: ABBV-927+ABBV-181', 'description': 'Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.', 'interventionNames': ['Drug: ABBV-927', 'Drug: ABBV-181']}], 'interventions': [{'name': 'ABBV-927', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['Escalating Arm 1: ABBV-927', 'Escalating Arm 3: ABBV-927+ABBV-181', 'Escalating Arm 5 (Japan): ABBV-927', 'Escalating Arm 6 (Japan): ABBV-927+ABBV-181', 'Expansion Arm A: ABBV-927', 'Expansion Arm C: ABBV-927+ABBV-181']}, {'name': 'ABBV-927', 'type': 'DRUG', 'description': 'Intratumoral', 'armGroupLabels': ['Escalating Arm 2: ABBV-927', 'Escalating Arm 4: ABBV-927+ABBV-181', 'Expansion Arm B: ABBV-927+ABBV-181']}, {'name': 'ABBV-181', 'type': 'DRUG', 'otherNames': ['Budigalimab'], 'description': 'Intravenous', 'armGroupLabels': ['Escalating Arm 3: ABBV-927+ABBV-181', 'Escalating Arm 4: ABBV-927+ABBV-181', 'Escalating Arm 6 (Japan): ABBV-927+ABBV-181', 'Expansion Arm B: ABBV-927+ABBV-181', 'Expansion Arm C: ABBV-927+ABBV-181']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Researc /ID# 156324', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60637-1443', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center /ID# 155264', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital /ID# 155267', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina BioOncology Institute /ID# 155265', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '37203-1632', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology-Nashville Centennial /ID# 158654', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center /ID# 155263', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists - Fairfax /ID# 155266', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peninsula Oncology Centre /ID# 164372', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health /ID# 171189', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network_Princess Margaret Cancer Centre /ID# 200819', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'Institut Bergonie /ID# 162665', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '34298', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'facility': 'Duplicate_Institut Regional du Cancer /ID# 163609', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '69373', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': 'Centre Leon Berard /ID# 162663', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Val-de-Marne', 'country': 'France', 'facility': 'Institut Gustave Roussy /ID# 162666', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East /ID# 216870'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital /ID# 217758'}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 166291', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System Severance Hospital /ID# 166292', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundacion Jimenez Diaz /ID# 200128', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HM Sanchinarro /ID# 200127', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politecnico La Fe /ID# 200975', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}