Actively Recruiting
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
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2026-03-17
52
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying bulumtatug fuvedotin to evaluate its potential effectiveness in patients with triple-negative breast cancer who have previously been treated with antibody-drug conjugates. This phase Ib, open-label trial focuses on patients with recurrent or metastatic disease to better understand the drug's impact in this specific group. The study is sponsored by Mabwell (Shanghai) Bioscience Co., Ltd. and aims to assess important outcomes related to tumor response and safety. Participants will receive bulumtatug fuvedotin through intravenous infusions on day 1 and day 8 of each 21-day cycle. Two different dose levels are being tested to compare their effects. The study employs a randomized design without masking, meaning both patients and researchers know the treatment being administered. The trial period for assessing outcomes is planned for up to approximately two years. During the study, participants will undergo regular evaluations including tumor measurements to assess response, blood tests to monitor drug levels and immune reactions, and safety checks for side effects. Researchers will monitor outcomes such as objective tumor response, disease control, survival, and drug pharmacokinetics. Participants must meet specific health criteria and will be followed closely throughout the study duration to gather comprehensive data on treatment effects and safety.
CONDITIONS
Brief Title
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has measurable disease by RECIST v1.1
- Recurrent or metastatic triple-negative breast cancer as per current ASCO/CAP guidelines
- Prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload
- 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 5 18 years
- Willing to receive blood transfusions if medically indicated
- ECOG performance status 0-1
- Adequate hematologic and organ function
- Life expectancy of at least 3 months as assessed by the investigator
- Compliance with contraceptive requirement
You will not qualify if you...
- 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 52 peripheral neuropathy
- Pregnant or breastfeeding women
- Life-threatening illness or uncontrolled medical conditions compromising safety or study outcomes
- Any systemic anticancer therapy in the last 28 days before study drug administration
- Active HCV, HBV, or HIV infection unless well controlled with antiviral therapy
- Active or chronic corneal disorder, keratitis, corneal ulcerations, or Sjogren's syndrome
- Ongoing acute inflammatory or uncontrolled chronic skin disease
- Another primary malignancy except adequately treated non-melanoma skin cancer, cervical cancer in situ, definitively treated non-metastatic prostate cancer, or relapse-free for at least 3 years
- Significant, uncontrolled, or active cardiovascular disease
- Active or history of pneumonitis or interstitial lung disease requiring corticosteroid treatment (radiation pneumonitis without treatment allowed)
- Uncontrolled diabetes
- Use of strong CYP3A4 inhibitors within 14 days prior to first dose
- Known hypersensitivity to bulumtatug fuvedotin or its components
- History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening
- Live vaccine within 30 days of planned start of study therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive bulumtatug fuvedotin via intravenous infusion on day 1 and day 8 of every 21-day cycle at assigned dose levels.
Infusions on day 1 and day 8 of each 21-day cycle
Trial Site Locations
Total: 6 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Anschutz Medical Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
Research Team
F
Fan Gao
W
Wenhui Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here