Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-04-15 @ 2:01 PM
Study NCT ID:
NCT05918692
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of BMF-500 in Adults With Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Accelerated Titration Design, Followed by Modified 3+3'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-06-23', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs).', 'timeFrame': 'At the end of each 28 Day cycle for a maximum of 32 cycles', 'description': 'Assessed by the NCI CTCAE version 5.0.'}, {'measure': 'Evaluate the safety and tolerability of BMF-500 by incidence of Serious Adverse Events (SAEs).', 'timeFrame': 'At the end of each 28 Day cycle for a maximum of 32 cycles', 'description': 'Assessed by the NCI CTCAE version 5.0.'}, {'measure': 'Determine the recommended Phase 2 Dose (RP2D) of BMF-500.', 'timeFrame': 'At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period', 'description': 'Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.'}, {'measure': 'Determine the recommended Phase 2 Dose (RP2D) of BMF-500.', 'timeFrame': 'At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period', 'description': 'Efficacy within each dose level as determined by composite complete remission (CRc).'}, {'measure': 'Determine the recommended Phase 2 Dose (RP2D) of BMF-500.', 'timeFrame': 'At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period', 'description': 'Pharmacovigilance (PK) at each dose level as determined by the maximum plasma concentration (Cmax).'}, {'measure': 'Determine the recommended Phase 2 Dose (RP2D) of BMF-500.', 'timeFrame': 'At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period', 'description': 'Pharmacovigilance (PK) at each dose level as determined by area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).'}], 'secondaryOutcomes': [{'measure': 'Determine the pharmacokinetics of BMF-500.', 'timeFrame': 'At the end of each cycle (each cycle is 28 days in duration) for 7 cycles', 'description': 'Maximum plasma concentration (Cmax).'}, {'measure': 'Determine the pharmacokinetics of BMF-500.', 'timeFrame': 'At the end of Cycle 1 and 2 (each cycle is 28 days in duration)', 'description': 'Area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).'}, {'measure': 'Evaluate the efficacy of BMF-500', 'timeFrame': 'At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles', 'description': 'Composite Complete Remission (CRc).'}, {'measure': 'Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.', 'timeFrame': 'At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles', 'description': 'Duration of Response (DOR).'}, {'measure': 'Evaluate the efficacy of BMF-500', 'timeFrame': 'At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles', 'description': 'Overall Reasons Rate (ORR).'}, {'measure': 'Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.', 'timeFrame': 'At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles', 'description': 'Relapse free survival (RFS).'}, {'measure': 'Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.', 'timeFrame': 'At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles', 'description': 'Overall Survival (OS).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FLT3', 'FLT3-ITD', 'FLT-TKD', 'AML', 'FLT3 Wild-Type', 'MLL-R', 'NPM1', 'CYP3A4'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral FLT3 inhibitor, in adult patients with acute leukemia.', 'detailedDescription': 'A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral covalent FLT3 inhibitor, in adult patients with acute myeloid leukemia (AML), who may or may not be on Antifungals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Individuals with histologically or pathologically confirmed diagnosis of relapsed or refractory AML with documented FLT3 mutation, and/or Individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type FLT3 (including those with MLL1-R and NPM1 mutations).\n* ECOG performance status of 0-2.\n* Adequate liver and renal function\n* Adhere to the CYP3A4 inhibitor concomitant therapy use requirements, as follows:\n* Arm A: Participants must not have received a moderate or strong CYP3A4 inhibitor for at least 7 days prior to enrollment and are not anticipated to require such agents in the near term (for at least 4 weeks).\n* Arm B: Participants must have received a necessary azole antifungal(s) that is a strong CYP3A4 inhibitor (excluding other strong CYP3A4 inhibitor\\[s\\]) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on BMF-500 treatment for at least 4 weeks.\n* Arm C: Participants must have received necessary azole antifungal(s) that are moderate CYP3A4 inhibitors (excluding other moderate CYP3A4 inhibitors) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on BMF-500 treatment for at least 4 weeks (Cycle 1).\n\nKey Exclusion Criteria:\n\n* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, history of cerebrovascular accident including transient ischemic attack within 6 months prior to the first dose of the trial intervention.\n* WBC count \\>50,000/µL (uncontrollable with cytoreductive therapy).\n* Women who are pregnant or lactating or plan to become pregnant.'}, 'identificationModule': {'nctId': 'NCT05918692', 'briefTitle': 'A Phase 1 Study of BMF-500 in Adults With Acute Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomea Fusion Inc.'}, 'officialTitle': 'A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study of BMF-500, an Oral Covalent FLT3 Inhibitor, in Adults With Acute Leukemia', 'orgStudyIdInfo': {'id': 'COVALENT-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Escalation Phase', 'description': 'BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity.', 'interventionNames': ['Drug: BMF-500']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Escalation Phase', 'description': 'BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors.', 'interventionNames': ['Drug: BMF-500']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Escalation Phase', 'description': 'BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.', 'interventionNames': ['Drug: BMF-500']}], 'interventions': [{'name': 'BMF-500', 'type': 'DRUG', 'description': 'Investigational Product', 'armGroupLabels': ['Arm A: Escalation Phase', 'Arm B: Escalation Phase', 'Arm C: Escalation Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky - Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-PA USOR', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '20155', 'city': 'Gainesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.79567, 'lon': -77.61388}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomea Fusion Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}