Tests bulumtatug fuvedotin in people with triple-negative breast cancer previously treated with ADCs
Tests bulumtatug fuvedotin in adults with triple-negative breast cancer after prior antibody-drug conjugate treatment.
Plain-language title generated from the registry record
Registry title: A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Key facts
- Where
- Aurora, Boston, Chicago, Duarte, La Jolla, Nashville, and New York, United StatesSee the 7 sites
- Phase
- Phase 1
Where in United States
- Anschutz Medical CenterAurora, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- UChicago Medicine Comprehensive Cancer CenterChicago, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- UCSD Moores Cancer CenterLa Jolla, United StatesTaking people
- Sarah Cannon Research Institute SCRINashville, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT06908928
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Patient has measurable disease by RECIST v1.1; Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines; Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload; Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting; Provision of archival tumor tissue or fresh tumor biopsy; Capable of giving informed consent; Male or female subjects aged ≥ 18 years; Subjects must be willing to receive blood transfusions if medically indicated; ECOG 0-1; Adequate hematologic and organ function; Life expectancy of at least 3 months as assessed by the investigator; Compliance with contraceptive requirement.
Exclusion: Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates; Any systemic anticancer therapy in the last 28 days prior to first administration of study drug; Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug; History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening; Have received a live vaccine within 30 days of planned start of study therapy; Acute infection requiring IV treatment in the last 14 days; Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk; Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy; Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome; Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled; 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; Have significant, uncontrolled or active cardiovascular disease; 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; Have uncontrolled diabetes; Unstable CNS metastasis requiring treatment in the last 28 days; Grade ≥2 peripheral neuropathy; Pregnant or breastfeeding women; Subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.