[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585942":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":26,"locations":35,"responsibleParty":119,"collaborators":11,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":11,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":11,"enrollmentInfo":130,"targetDuration":11,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose level 1 of BFv","EXPERIMENTAL",null,[13],"Drug: bulumtatug fuvedotin",{"label":15,"type":10,"description":11,"interventionNames":16},"Dose level 2 of BFv",[13],[18,23],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","bulumtatug fuvedotin","given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1",[9],{"type":19,"name":20,"description":24,"armGroupLabels":25,"otherNames":11},"given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2",[15],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Fan Gao","CONTACT","+8615122736763","fan.gao@mabwell.com",{"name":33,"role":29,"phone":11,"phoneExt":11,"email":34},"Wenhui Zhang, MD","wenhui.zhang@mabwell.com",[36,56,70,80,95,105],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.97729,34.13945,{"lat":48,"lon":47},[51,53],{"name":11,"role":29,"phone":52,"phoneExt":11,"email":11},"877-460-2954",{"name":54,"role":55,"phone":11,"phoneExt":11,"email":11},"Hope Rugo","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":38,"city":58,"state":40,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"UCSD Moores Cancer Center","La Jolla","92093",{"type":45,"coordinates":61},[62,63],-117.2742,32.84727,{"lat":63,"lon":62},[66,68],{"name":11,"role":29,"phone":67,"phoneExt":11,"email":11},"866-773-2703",{"name":69,"role":55,"phone":11,"phoneExt":11,"email":11},"Rebecca Shatsky",{"facility":71,"status":38,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":11},"Anschutz Medical Center","Aurora","Colorado","80045",{"type":45,"coordinates":76},[77,78],-104.83192,39.72943,{"lat":78,"lon":77},{"facility":81,"status":38,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"UChicago Medicine Comprehensive Cancer Center","Chicago","Illinois","60637",{"type":45,"coordinates":86},[87,88],-87.65005,41.85003,{"lat":88,"lon":87},[91,93],{"name":11,"role":29,"phone":92,"phoneExt":11,"email":11},"855-702-8222",{"name":94,"role":55,"phone":11,"phoneExt":11,"email":11},"Rita Nanda",{"facility":96,"status":38,"city":97,"state":98,"zip":99,"country":42,"countryCode":43,"cosmosGeoPoint":100,"geoPoint":104,"contacts":11},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":45,"coordinates":101},[102,103],-71.05977,42.35843,{"lat":103,"lon":102},{"facility":106,"status":38,"city":107,"state":107,"zip":108,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Memorial Sloan Kettering Cancer Center","New York","10021",{"type":45,"coordinates":110},[111,112],-74.00597,40.71427,{"lat":112,"lon":111},[115,117],{"name":11,"role":29,"phone":116,"phoneExt":11,"email":11},"646-888-6885",{"name":118,"role":55,"phone":11,"phoneExt":11,"email":11},"Nour Abuhadra",{"type":120,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100585942","phase-1-a-dose-randomization-study-of-bulumtatug-fuvedotin-in-tnbc-patients-previously-treated-with-adcs-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":131,"type":132},52,"ESTIMATED","INTERVENTIONAL",[135],"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.",[138],"Triple Negative Breast Cancer",[140,20],"9MW2821","2026-03-16",{"date":143,"type":144},"2026-03-17","ACTUAL",{"date":146,"type":144},"2025-08-11",{"date":148,"type":132},"2028-05",{"name":5,"class":6},6]