Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:02 PM
Study NCT ID:
NCT06908928
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Efficacy parameters and biomarkers including but not limited to nectin-4 expression level.', 'timeFrame': 'Up to approximately 2 years', 'description': 'The proportion of nectin-4 positive and negative patients. The proportion of nectin-4 positive patients who experienced objective response. The proportion of nectin-4 negative patients who experienced objective response.'}], 'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'Objective Response Rate according to RECIST v1.1 by investigator assessment'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'The percentage of patients who achieve CR, PR, or SD for at least 6 months.'}, {'measure': 'Duration of response', 'timeFrame': 'Up to approximately 2 years', 'description': 'The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to approximately 2 years', 'description': 'The time from treatment initiation to disease progression or death from any cause.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to approximately 2 years', 'description': 'The time from treatment initiation to death from any cause.'}, {'measure': 'Time to Maximum Concentration (Tmax)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Time to reach the maximum observed concentration of bulumtatug fuvedotin, TAb, and MMAE in blood.'}, {'measure': 'Maximum Concentration (Cmax)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Maximum observed blood concentration of bulumtatug fuvedotin, TAb, and MMAE.'}, {'measure': 'Half-life (t1/2)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The time required for the blood concentration of bulumtatug fuvedotin, TAb, and MMAE to decrease by 50%.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The area under the plasma concentration-time curve from time zero to the last measurable concentration for bulumtatug fuvedotin, TAb, and MMAE.'}, {'measure': 'Incidence, rate and severity of treatment-emergent adverse events.', 'timeFrame': 'Up to approximately 2 years', 'description': 'Incidence, rate and severity of AE, SAE, TRAE and AESI. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record. Safety will be reported as incidence and rate of treatment-emergent adverse events using NCI CTCAE v5.0 criteria.'}, {'measure': 'Immunogenicity', 'timeFrame': 'Up to approximately 2 years', 'description': 'Incidence and rates of ADA and Nab.'}, {'measure': 'Immunogenicity', 'timeFrame': 'Up to approximately 2 years', 'description': 'Titre of ADA and Nab.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['9MW2821', 'bulumtatug fuvedotin'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Patient has measurable disease by RECIST v1.1\n* Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines\n* Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.\n* Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.\n* Provision of archival tumor tissue or fresh tumor biopsy.\n* Capable of giving informed consent\n* Male or female subjects aged ≥ 18 years.\n* Subjects must be willing to receive blood transfusions if medically indicated.\n* ECOG 0-1\n* Adequate hematologic and organ function\n* Life expectancy of at least 3 months as assessed by the investigator\n* Compliance with contraceptive requirement\n\nExclusion Criteria:\n\n* Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.\n* Unstable CNS metastasis requiring treatment in the last 28 days.\n* Acute infection requiring IV treatment in the last 14 days.\n* Grade ≥2 peripheral neuropathy.\n* Pregnant or breastfeeding women.\n* Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk\n* Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.\n* Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy.\n* Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome.\n* Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled.\n* Have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n* Have significant, uncontrolled or active cardiovascular disease\n* Have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. Patients with radiation pneumonitis that does not require treatment is allowed.\n* Have uncontrolled diabetes.\n* Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.\n* Subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.\n* History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.\n* Have received a live vaccine within 30 days of planned start of study therapy."}, 'identificationModule': {'nctId': 'NCT06908928', 'briefTitle': 'A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mabwell (Shanghai) Bioscience Co., Ltd.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates', 'orgStudyIdInfo': {'id': '9MW2821-2022-CP103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose level 1 of BFv', 'interventionNames': ['Drug: bulumtatug fuvedotin']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level 2 of BFv', 'interventionNames': ['Drug: bulumtatug fuvedotin']}], 'interventions': [{'name': 'bulumtatug fuvedotin', 'type': 'DRUG', 'description': 'given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1', 'armGroupLabels': ['Dose level 1 of BFv']}, {'name': 'bulumtatug fuvedotin', 'type': 'DRUG', 'description': 'given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2', 'armGroupLabels': ['Dose level 2 of BFv']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hope Rugo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '866-773-2703'}, {'name': 'Rebecca Shatsky', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSD Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '855-702-8222'}, {'name': 'Rita Nanda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UChicago Medicine Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '646-888-6885'}, {'name': 'Nour Abuhadra', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '615-329-7640'}, {'name': 'Erika Hamilton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Fan Gao', 'role': 'CONTACT', 'email': 'fan.gao@mabwell.com', 'phone': '+8615122736763'}, {'name': 'Wenhui Zhang, MD', 'role': 'CONTACT', 'email': 'wenhui.zhang@mabwell.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mabwell (Shanghai) Bioscience Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}