Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 4:56 PM
Study NCT ID:
NCT07077434
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Safety, Tolerability and Drug Levels of BMS-986504 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of BMS-986504', 'timeFrame': 'Up to approximately Day 64'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504', 'timeFrame': 'Up to approximately Day 64'}, {'measure': 'Area Under Curve (AUC) of BMS-986504', 'timeFrame': 'Up to approximately Day 64'}, {'measure': 'Mean Elimination Half-life (T-HALF) of BMS-986504', 'timeFrame': 'Up to approximately Day 64'}, {'measure': 'Apparent Total Body Clearance (CLT/F) of BMS-986504', 'timeFrame': 'Up to approximately Day 64'}, {'measure': 'Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504', 'timeFrame': 'Up to approximately Day 64'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Up to approximately Day 25'}, {'measure': 'Number of Participants With Treatment-related Adverse Events (AE)', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With all-cause AEs', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With Treatment-related Serious AEs (SAEs)', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With all-cause SAEs', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With AEs Leading to Dose Interruption', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With AEs Leading to Dose Reduction', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With AEs Leading to Treatment Discontinuation', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With AEs Leading to Death', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'Up to approximately 28 days after last dose of BMS-986504'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MTAP', 'PRMT5', 'MRTX1719', 'CDKN2A'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986504 in participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis.\n* Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT07077434', 'briefTitle': 'A Study to Assess Safety, Tolerability and Drug Levels of BMS-986504 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of BMS-986504 in Japanese and Chinese Participants With Advanced Solid Tumors With Homozygous MTAP Deletion', 'orgStudyIdInfo': {'id': 'CA240-0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986504 Arm', 'interventionNames': ['Drug: BMS-986504']}], 'interventions': [{'name': 'BMS-986504', 'type': 'DRUG', 'otherNames': ['MRTX1719'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986504 Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lin shen, Site 0001', 'role': 'CONTACT', 'phone': '8601088196340'}], 'facility': 'Beijing Cancer hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Lin, Site 0002', 'role': 'CONTACT', 'phone': '8613225999969'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Xiao, Site 0010', 'role': 'CONTACT', 'phone': '+8613711114566'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shubin wang, Site 0009', 'role': 'CONTACT', 'phone': '13823394076'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 0006', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0006', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '453100', 'city': 'Xinxiang', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 0011', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0011', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 0007', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuchao Wang, Site 0012', 'role': 'CONTACT', 'phone': '13752038814'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '2418515', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Makoto Ueno, Site 0003', 'role': 'CONTACT', 'phone': '+81-45-520-2222'}], 'facility': 'Kanagawa cancer center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ryo Ko, Site 0008', 'role': 'CONTACT', 'phone': '+81-55-989-5222'}], 'facility': 'Shizuoka Cancer Center'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Jun Sato, Site 0005', 'role': 'CONTACT', 'phone': '+81-3-3542-2511'}], 'facility': 'National Cancer Center Hospital'}, {'zip': '135-8550', 'city': 'Koto-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shigehisa Kitano, Site 0004', 'role': 'CONTACT', 'phone': '+81-3-3520-0111'}], 'facility': 'The Cancer Institute Hospital of JFCR'}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center, www.BMSStudyConnect.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. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}