Actively Recruiting
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2026-03-17
52
Participants Needed
6
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 per ASCO/CAP guidelines
- Prior treatment with taxane and antibody-drug conjugate with topoisomerase inhibitor payload
- No more than 3 prior lines of cytotoxic therapy for locally advanced or metastatic disease
- Provision of archival tumor tissue or fresh biopsy
- Able to give informed consent
- Male or female aged 18 years or older
- Willing to receive blood transfusions if medically needed
- ECOG performance status 0-1
- Adequate hematologic and organ function
- Life expectancy of at least 3 months
- Compliance with contraceptive requirements
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 within 28 days
- Acute infection needing IV treatment within 14 days
- Grade 2 or higher peripheral neuropathy
- Pregnant or breastfeeding women
- Life-threatening illness or uncontrolled medical conditions
- Systemic anticancer therapy within 28 days before study drug
- Active HCV, HBV, or HIV infection unless well controlled
- Active or chronic corneal disorders or Sjogren's syndrome
- Ongoing acute or uncontrolled chronic inflammatory skin disease
- Other primary malignancies unless adequately treated or relapse-free for at least 3 years
- Significant uncontrolled cardiovascular disease
- Active or history of pneumonitis or interstitial lung disease requiring corticosteroids
- Uncontrolled diabetes
- Use of strong CYP3A4 inhibitors within 14 days before study drug
- Hypersensitivity to bulumtatug fuvedotin or formulation components
- History of drug abuse within 12 months
- Live vaccine within 30 days before starting study therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
W
Wenhui Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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