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
1 other identifier
interventional
52
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2025
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2025
CompletedFirst Posted
Study publicly available on registry
April 3, 2025
CompletedStudy Start
First participant enrolled
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
March 17, 2026
August 1, 2025
1.7 years
March 20, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Objective Response Rate according to RECIST v1.1 by investigator assessment
Up to approximately 2 years
Secondary Outcomes (12)
Disease control rate
Up to approximately 2 years
Clinical benefit rate
Up to approximately 2 years
Duration of response
Up to approximately 2 years
Progression-free survival
Up to approximately 2 years
Overall survival
Up to approximately 2 years
- +7 more secondary outcomes
Other Outcomes (1)
Efficacy parameters and biomarkers including but not limited to nectin-4 expression level.
Up to approximately 2 years
Study Arms (2)
Dose level 1 of BFv
EXPERIMENTALDose level 2 of BFv
EXPERIMENTALInterventions
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.
- Unstable CNS metastasis requiring treatment in the last 28 days.
- Acute infection requiring IV treatment in the last 14 days.
- Grade ≥2 peripheral neuropathy.
- Pregnant or breastfeeding women.
- Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk
- Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.
- 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.
- Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
City of Hope
Duarte, California, 91010, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
Anschutz Medical Center
Aurora, Colorado, 80045, United States
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2025
First Posted
April 3, 2025
Study Start
August 11, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
March 17, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share