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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2
City of Hope
Duarte, California, United States
RECRUITINGUCSD Moores Cancer Center
La Jolla, California, United States
RECRUITINGAnschutz Medical Center
Aurora, Colorado, United States
Objective Response Rate
Objective Response Rate according to RECIST v1.1 by investigator assessment
Time frame: Up to approximately 2 years
Disease control rate
The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.
Time frame: Up to approximately 2 years
Clinical benefit rate
The percentage of patients who achieve CR, PR, or SD for at least 6 months.
Time frame: Up to approximately 2 years
Duration of response
The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.
Time frame: Up to approximately 2 years
Progression-free survival
The time from treatment initiation to disease progression or death from any cause.
Time frame: Up to approximately 2 years
Overall survival
The time from treatment initiation to death from any cause.
Time frame: Up to approximately 2 years
Time to Maximum Concentration (Tmax)
Time to reach the maximum observed concentration of bulumtatug fuvedotin, TAb, and MMAE in blood.
Time frame: Up to approximately 2 years
Maximum Concentration (Cmax)
Maximum observed blood concentration of bulumtatug fuvedotin, TAb, and MMAE.
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UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGTime frame: Up to approximately 2 years
Half-life (t1/2)
The time required for the blood concentration of bulumtatug fuvedotin, TAb, and MMAE to decrease by 50%.
Time frame: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
The area under the plasma concentration-time curve from time zero to the last measurable concentration for bulumtatug fuvedotin, TAb, and MMAE.
Time frame: Up to approximately 2 years
Incidence, rate and severity of treatment-emergent adverse events.
Incidence, rate and severity of AE, SAE, TRAE and AESI. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record. Safety will be reported as incidence and rate of treatment-emergent adverse events using NCI CTCAE v5.0 criteria.
Time frame: Up to approximately 2 years
Immunogenicity
Incidence and rates of ADA and Nab.
Time frame: Up to approximately 2 years
Immunogenicity
Titre of ADA and Nab.
Time frame: Up to approximately 2 years