Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06158958
Status:
TERMINATED
Last Update Posted:
2025-10-27
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults 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': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, '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': 27}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-11-29', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AE)', 'timeFrame': 'Up to 3 Years', 'description': 'An AE is 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': 'Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1', 'timeFrame': 'Up to 3 Years', 'description': 'ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to RECIST version 1.1.'}, {'measure': 'Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1', 'timeFrame': 'Up to 3 Years', 'description': 'DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 3 Years', 'description': 'PFS is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 3 Years', 'description': 'OS is defined as time from first study treatment to death due to any cause.'}, {'measure': 'ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)', 'timeFrame': 'Up to 3 Years', 'description': 'ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to iRECIST version 1.1.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid Tumors', 'Non-Small Cell Lung Cancer', 'NSCLC', 'Renal Cell Carcinoma', 'RCC', 'Head and Neck Squamous Cell Carcinoma', 'HNSCC', 'ABBV-303', 'ABBV-181', 'Budigalimab'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-122', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181).\n\nABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide.\n\nIn Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 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* Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug.\n* Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization \\[WHO\\] criteria).\n* Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n\nExclusion Criteria:\n\n* Unresolved Grade \\> 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia.\n* Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy.\n* History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181).\n* Body weight \\< 35 kg."}, 'identificationModule': {'nctId': 'NCT06158958', 'briefTitle': 'A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'M24-122'}, 'secondaryIdInfos': [{'id': '2023-504714-30', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Escalation: Part 1A Monotherapy', 'description': 'Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Expansion: Part 2A Monotherapy', 'description': 'Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Expansion: Part 3A Monotherapy', 'description': 'Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Expansion: Part 4A Monotherapy', 'description': 'Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Expansion: Part 5A Monotherapy', 'description': 'Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Escalation: Part 1B Combination', 'description': 'Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303', 'Drug: Budigalimab']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-303 Dose Expansion: Part 2B Combination', 'description': 'Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.', 'interventionNames': ['Drug: ABBV-303', 'Drug: Budigalimab']}], 'interventions': [{'name': 'ABBV-303', 'type': 'DRUG', 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['ABBV-303 Dose Escalation: Part 1A Monotherapy', 'ABBV-303 Dose Escalation: Part 1B Combination', 'ABBV-303 Dose Expansion: Part 2A Monotherapy', 'ABBV-303 Dose Expansion: Part 2B Combination', 'ABBV-303 Dose Expansion: Part 3A Monotherapy', 'ABBV-303 Dose Expansion: Part 4A Monotherapy', 'ABBV-303 Dose Expansion: Part 5A Monotherapy']}, {'name': 'Budigalimab', 'type': 'DRUG', 'otherNames': ['ABBV-181'], 'description': 'IV Infusion', 'armGroupLabels': ['ABBV-303 Dose Escalation: Part 1B Combination', 'ABBV-303 Dose Expansion: Part 2B Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope /ID# 254303', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California /ID# 254356', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '49546-7062', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'START Midwest /ID# 256945', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 262943', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina BioOncology Institute /ID# 254305', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University - The James /ID# 260475', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center /ID# 254308', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'NEXT Oncology /ID# 257395', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics /ID# 256944', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center /ID# 259408', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus /ID# 254608', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center-Hebrew University /ID# 254606', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East /ID# 261712'}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center /ID# 261714'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital /ID# 254359'}, {'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Wakayama Medical University Hospital /ID# 254361', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}