Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT06730750
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-12-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participnats with Adverse Events (AEs)', 'timeFrame': 'Up to 100 days following discontinuation of dosing'}, {'measure': 'Number of participants with Serious AEs (SAEs)', 'timeFrame': 'Up to 100 days following discontinuation of dosing'}, {'measure': 'Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria', 'timeFrame': 'Up to 28 days after the first treatment of study intervention'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to 100 days following discontinuation of dosing'}, {'measure': 'Number of deaths', 'timeFrame': 'Up to 100 days following discontinuation of dosing'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve in 1 dosing interval (AUC(TAU))', 'timeFrame': 'Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)'}, {'measure': 'Trough observed concentration (Ctrough)', 'timeFrame': 'Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)'}, {'measure': 'Total anti-drug antibodies (ADAs)', 'timeFrame': 'Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)'}, {'measure': 'Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator', 'timeFrame': 'Up to approximately 4 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer (CRC)', 'Non-small Cell Lung cancer (NSCLC)', 'Gastric Cancer (GC)'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06730750.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.\n* CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:\n\n i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).\n* NSCLC: Part 2A-NSCLC/GC, 2L+ NSCLC:\n\n i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.\n\nii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.\n\n\\- GC: Part 2A-NSCLC/GC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).\n\nii) ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n* History of anaphylactic reactions to irinotecan and/or bevacizumab.\n* Previously received therapy targeting CEACAM5.\n* Grade ≥3 ILD/pneumonitis.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06730750', 'briefTitle': 'A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CA238-0001'}, 'secondaryIdInfos': [{'id': '2024-518421-14', 'type': 'OTHER', 'domain': 'EU CTR'}, {'id': 'U1111-1313-7004', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A', 'interventionNames': ['Drug: BMS-986490']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2A - Colorectal Cancer (CRC)', 'interventionNames': ['Drug: BMS-986490']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)', 'interventionNames': ['Drug: BMS-986490']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B', 'interventionNames': ['Drug: BMS-986490', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2B', 'interventionNames': ['Drug: BMS-986490', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'BMS-986490', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Part 1A', 'Part 1B', 'Part 2A - Colorectal Cancer (CRC)', 'Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)', 'Part 2B']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Part 1B', 'Part 2B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heinz-Josef Lenz, Site 0007', 'role': 'CONTACT', 'phone': '323-865-3967'}], 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nehal Lakhani, Site 0017', 'role': 'CONTACT', 'phone': '616-954-5554'}], 'facility': 'START Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Martin Gutierrez, Site 0004', 'role': 'CONTACT', 'phone': '551-996-5863'}], 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anwaar Saeed, Site 0006', 'role': 'CONTACT', 'phone': '816-898-9413'}], 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Andrew Hill, Site 0012', 'role': 'CONTACT', 'phone': '+61756132480'}], 'facility': 'Tasman Oncology Research', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anna Spreafico, Site 0003', 'role': 'CONTACT', 'phone': '4169464501'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'BMS Clinical Trials Contact Center www.BMSClinicalTrials.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain the NCT# and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See Plan Description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}