Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-05 @ 12:41 AM
Study NCT ID:
NCT06487559
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver 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': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AE)', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants with Dose-Limiting Toxicities (DLT)', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab'}, {'measure': 'Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'AUC of livmoniplimab and Budigalimab'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'Defined as achieving either confirmed CR or confirmed PR per RECIST v1.1 as assessed by the investigator.'}, {'measure': 'Duration of response (DOR) for Participants with Confirmed CR/PR', 'timeFrame': 'Up to Approximately 2 Years', 'description': "Defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause."}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to Approximately 2 Years', 'description': "Defined as the time from the participant's first dose of study drug until radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first."}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to Approximately 2 Years', 'description': "Defined as the time from the participant's first dose of study drug until death from any cause."}, {'measure': 'Antidrug Antibody (ADA)', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'Incidence and concentration of anti-drug antibodies.'}, {'measure': 'Neutralizing Antidrug Antibody (nADA)', 'timeFrame': 'Up to Approximately 2 Years', 'description': 'Incidence and concentration of neutralizing anti-drug antibodies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma (HCC)', 'Livmoniplimab', 'ABBV-151', 'budigalimab', 'ABBV-181'], 'conditions': ['Hepatocellular Carcinoma (HCC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-695', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma (HCC).\n\nLivmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. Stage 1 is a safety run-in. There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab (fixed dose). Stage 2 is dose expansion. There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses. Approximately 20 adult participants will be enrolled in the study across 15 sites in China.\n\nIn part 1 (dose escalation), participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks. In part 2 (dose expansion), participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks. The estimated duration of the study is 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 and may require frequent medical assessments, blood tests, and scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Locally advanced or metastatic and/or unresectable HCC\n* Child-Pugh A\n* Barcelona Clinic Liver Cancer stage B or C\n* Eastern Cooperative Oncology Group (ECOG) Perfromance Status of 0-1\n* Received an immune checkpoint inhibitor in 1L HCC treatment regimen\n* Adequate hematologic and end-organ function\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as outlined in the protocol.\n* History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%).\n* History of autoimmune, immune deficiency, or inflammatory disorders including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, rheumatoid arthritis, antiphospholipid antibody syndrome, Guillain-Barre syndrome, or multiple sclerosis\n* History of clinically significant conditions such as but not limited to the following: renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that in Investigator's opinion, would adversely affect the subject's participation in the study."}, 'identificationModule': {'nctId': 'NCT06487559', 'briefTitle': 'A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor', 'orgStudyIdInfo': {'id': 'M24-695'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A', 'description': 'Participants will receive livmoniplimab Dose A in combination with budigalimab every 3 weeks for approximately 2 years.', 'interventionNames': ['Drug: Livmoniplimab', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B', 'description': 'Participants will receive livmoniplimab Dose B in combination with budigalimab every 3 weeks for approximately 2 years.', 'interventionNames': ['Drug: Livmoniplimab', 'Drug: Budigalimab']}], 'interventions': [{'name': 'Livmoniplimab', 'type': 'DRUG', 'otherNames': ['ABBV-151'], 'description': 'Intravenous infusion', 'armGroupLabels': ['Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A', 'Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B']}, {'name': 'Budigalimab', 'type': 'DRUG', 'otherNames': ['ABBV-181'], 'description': 'Intravenous infusion', 'armGroupLabels': ['Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A', 'Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350012', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center /ID# 262092', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University /ID# 262091', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital /Id# 262070', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Henan Cancer Hospital /ID# 262098', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hubei Cancer Hospital /ID# 262030', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '330008', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanchang University /ID# 262085', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Liaoning Cancer Hospital & Institute /ID# 268023', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University /ID# 262135', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Zhejiang Cancer hospital /ID# 262046', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], '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'}}}}