[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585942":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":56,"studyPopulation":56,"armGroups":60,"interventions":69,"overallOfficials":56,"centralContacts":78,"locations":87,"responsibleParty":171,"collaborators":56,"id":173,"slug":56,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":56,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":56,"enrollmentInfo":181,"targetDuration":56,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":90,"whyStopped":56,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate","Objective Response Rate according to RECIST v1.1 by investigator assessment","Up to approximately 2 years",[14,17,20,23,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":12},"Disease control rate","The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.",{"measure":18,"description":19,"timeFrame":12},"Clinical benefit rate","The percentage of patients who achieve CR, PR, or SD for at least 6 months.",{"measure":21,"description":22,"timeFrame":12},"Duration of response","The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.",{"measure":24,"description":25,"timeFrame":12},"Progression-free survival","The time from treatment initiation to disease progression or death from any cause.",{"measure":27,"description":28,"timeFrame":12},"Overall survival","The time from treatment initiation to death from any cause.",{"measure":30,"description":31,"timeFrame":12},"Time to Maximum Concentration (Tmax)","Time to reach the maximum observed concentration of bulumtatug fuvedotin, TAb, and MMAE in blood.",{"measure":33,"description":34,"timeFrame":12},"Maximum Concentration (Cmax)","Maximum observed blood concentration of bulumtatug fuvedotin, TAb, and MMAE.",{"measure":36,"description":37,"timeFrame":12},"Half-life (t1\u002F2)","The time required for the blood concentration of bulumtatug fuvedotin, TAb, and MMAE to decrease by 50%.",{"measure":39,"description":40,"timeFrame":12},"Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)","The area under the plasma concentration-time curve from time zero to the last measurable concentration for bulumtatug fuvedotin, TAb, and MMAE.",{"measure":42,"description":43,"timeFrame":12},"Incidence, rate and severity of treatment-emergent adverse events.","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":45,"description":46,"timeFrame":12},"Immunogenicity","Incidence and rates of ADA and Nab.",{"measure":45,"description":48,"timeFrame":12},"Titre of ADA and Nab.",[50],{"measure":51,"description":52,"timeFrame":12},"Efficacy parameters and biomarkers including but not limited to nectin-4 expression level.","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.",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":56,"timePerspective":56,"maskingInfo":58},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":59,"maskingDescription":56,"whoMasked":56},"NONE",[61,66],{"label":62,"type":63,"description":56,"interventionNames":64},"Dose level 1 of BFv","EXPERIMENTAL",[65],"Drug: bulumtatug fuvedotin",{"label":67,"type":63,"description":56,"interventionNames":68},"Dose level 2 of BFv",[65],[70,75],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":56},"DRUG","bulumtatug fuvedotin","given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1",[62],{"type":71,"name":72,"description":76,"armGroupLabels":77,"otherNames":56},"given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2",[67],[79,84],{"name":80,"role":81,"phone":82,"phoneExt":56,"email":83},"Fan Gao","CONTACT","+8615122736763","fan.gao@mabwell.com",{"name":85,"role":81,"phone":56,"phoneExt":56,"email":86},"Wenhui Zhang, MD","wenhui.zhang@mabwell.com",[88,108,122,132,147,157],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-117.97729,34.13945,{"lat":100,"lon":99},[103,105],{"name":56,"role":81,"phone":104,"phoneExt":56,"email":56},"877-460-2954",{"name":106,"role":107,"phone":56,"phoneExt":56,"email":56},"Hope Rugo","PRINCIPAL_INVESTIGATOR",{"facility":109,"status":90,"city":110,"state":92,"zip":111,"country":94,"countryCode":95,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"UCSD Moores Cancer Center","La Jolla","92093",{"type":97,"coordinates":113},[114,115],-117.2742,32.84727,{"lat":115,"lon":114},[118,120],{"name":56,"role":81,"phone":119,"phoneExt":56,"email":56},"866-773-2703",{"name":121,"role":107,"phone":56,"phoneExt":56,"email":56},"Rebecca Shatsky",{"facility":123,"status":90,"city":124,"state":125,"zip":126,"country":94,"countryCode":95,"cosmosGeoPoint":127,"geoPoint":131,"contacts":56},"Anschutz Medical Center","Aurora","Colorado","80045",{"type":97,"coordinates":128},[129,130],-104.83192,39.72943,{"lat":130,"lon":129},{"facility":133,"status":90,"city":134,"state":135,"zip":136,"country":94,"countryCode":95,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"UChicago Medicine Comprehensive Cancer Center","Chicago","Illinois","60637",{"type":97,"coordinates":138},[139,140],-87.65005,41.85003,{"lat":140,"lon":139},[143,145],{"name":56,"role":81,"phone":144,"phoneExt":56,"email":56},"855-702-8222",{"name":146,"role":107,"phone":56,"phoneExt":56,"email":56},"Rita Nanda",{"facility":148,"status":90,"city":149,"state":150,"zip":151,"country":94,"countryCode":95,"cosmosGeoPoint":152,"geoPoint":156,"contacts":56},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":97,"coordinates":153},[154,155],-71.05977,42.35843,{"lat":155,"lon":154},{"facility":158,"status":90,"city":159,"state":159,"zip":160,"country":94,"countryCode":95,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Memorial Sloan Kettering Cancer Center","New York","10021",{"type":97,"coordinates":162},[163,164],-74.00597,40.71427,{"lat":164,"lon":163},[167,169],{"name":56,"role":81,"phone":168,"phoneExt":56,"email":56},"646-888-6885",{"name":170,"role":107,"phone":56,"phoneExt":56,"email":56},"Nour Abuhadra",{"type":172,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100585942",false,"NCT06908928","A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs","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","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\u002FCAP 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.","ALL","18 Years",{"count":182,"type":183},52,"ESTIMATED","INTERVENTIONAL",[186],"PHASE1","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.",[189],"Triple Negative Breast Cancer",[191,72],"9MW2821","2026-03-16",{"date":194,"type":195},"2026-03-17","ACTUAL",{"date":197,"type":195},"2025-08-11",{"date":199,"type":183},"2028-05",{"name":5,"class":6},6]