Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-20 @ 6:22 AM
Study NCT ID:
NCT06299761
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-05', 'releaseDate': '2025-08-19'}, {'releaseDate': '2025-12-23'}], 'estimatedResultsFirstSubmitDate': '2025-08-19'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'BBI-825 single agent dose escalation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825', 'timeFrame': 'Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)', 'description': 'TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.'}, {'measure': 'Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825', 'timeFrame': 'Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)', 'description': 'The MTD and/or RP2D of BBI-825 will be determined.'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BBI-825', 'timeFrame': 'Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)', 'description': 'Maximum observed plasma concentration (Cmax) of BBI-825 will be determined.'}, {'measure': 'Trough observed plasma concentration (Ctrough) of BBI-825', 'timeFrame': 'Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)', 'description': 'Trough observed plasma concentration (Ctrough) of BBI-825 will be determined.'}, {'measure': 'Time to Cmax (Tmax) of BBI-825', 'timeFrame': 'Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)', 'description': 'Time to Cmax (Tmax) of BBI-825 will be determined.'}, {'measure': 'Area under the concentration time curve (AUC) of BBI-825', 'timeFrame': 'Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)', 'description': 'Area under the concentration time curve (AUC) of BBI-825 will be determined.'}, {'measure': 'Anti-tumor activity of BBI-825 as determined by RECISTv1.1', 'timeFrame': 'Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)', 'description': 'Number of participants achieving a best response of progressive disease, stable disease, partial response, or complete response.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amplification', 'Oncogene Amplification', 'ribonucleotide reductase inhibitor', 'RNR inhibitor'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.', 'detailedDescription': 'BBI-825 will be administered orally (PO) twice daily (BID) to subjects with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists,\n* Availability of FFPE tumor tissue, archival or newly obtained,\n* Measurable disease as defined by RECIST Version 1.1,\n* Adequate hematologic function,\n* Adequate hepatic and renal function,\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,\n* Other inclusion criteria per study protocol.\n\nExclusion Criteria:\n\n* Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted),\n* Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives,\n* Hematologic malignancies,\n* Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,\n* Prior or concurrent malignancies, with exceptions per study protocol,\n* History of HBV, HCV, or HIV infection,\n* Clinically significant cardiac condition,\n* Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,\n* QTcF \\> 470 msec,\n* Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19,\n* Other exclusion criteria per study protocol.'}, 'identificationModule': {'nctId': 'NCT06299761', 'acronym': 'STARMAP', 'briefTitle': 'Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boundless Bio'}, 'officialTitle': 'An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications', 'orgStudyIdInfo': {'id': 'BBI-825-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Agent Dose Escalation', 'description': 'Single agent BBI-825, administered orally, twice daily, in 28-day cycles', 'interventionNames': ['Drug: BBI-825']}], 'interventions': [{'name': 'BBI-825', 'type': 'DRUG', 'otherNames': ['ribonucleotide reductase inhibitor'], 'description': 'Oral RNR inhibitor', 'armGroupLabels': ['Single Agent Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Sarcoma Oncology Research Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'START Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75039', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert Doebele, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boundless Bio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boundless Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-19', 'type': 'RELEASE'}, {'date': '2025-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Boundless Bio'}}}}