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
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.
Arms & interventions
- Drugbulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
- Drugbulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2
Outcome measures
Primary
Objective Response Rate
Objective Response Rate according to RECIST v1.1 by investigator assessment
Time frame: Up to approximately 2 years
Secondary
Disease control rate
Time frame: Up to approximately 2 years
Clinical benefit rate
Time frame: Up to approximately 2 years
Duration of response
Time frame: Up to approximately 2 years
Progression-free survival
Time frame: Up to approximately 2 years
Overall survival
Time frame: Up to approximately 2 years
Time to Maximum Concentration (Tmax)
Time frame: Up to approximately 2 years
Maximum Concentration (Cmax)
Time frame: Up to approximately 2 years
Half-life (t1/2)
Time frame: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
Time frame: Up to approximately 2 years
Incidence, rate and severity of treatment-emergent adverse events.
Time frame: Up to approximately 2 years
Immunogenicity
Time frame: Up to approximately 2 years
Immunogenicity
Time frame: Up to approximately 2 years
Eligibility criteria
Study locations (6)
City of Hope
Duarte, California, 91010
UCSD Moores Cancer Center
La Jolla, California, 92093
Anschutz Medical Center
Aurora, Colorado, 80045
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Massachusetts General Hospital
Boston, Massachusetts, 02114
Memorial Sloan Kettering Cancer Center
New York, New York, 10021