This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
436
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
BICR-assessed Progression-free Survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Time frame: Up to approximately 24 months
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Time frame: Up to approximately 24 months
Investigator-assessed Progression-free Survival (PFS)
Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Time frame: Up to approximately 24 months
Time to Response (TTR)
Time to Response (TTR) is defined as the time from randomization to the first documented response (CR or PR) according to RECIST v1.1 criteria.
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
Time frame: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.
Time frame: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.
Time frame: Up to approximately 24 months
T1/2
Half-life (T1/2) of BL-B01D1 will be investigated.
Time frame: Up to approximately 24 months
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Time frame: Up to approximately 24 months
CL (Clearance)
CL in the serum of BL-B01D1 per unit of time will be investigated.
Time frame: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.
Time frame: Up to approximately 24 months
Anti-drug Antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Time frame: Up to approximately 24 months
Neutralizing Antibody(NAb)
Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.
Time frame: Up to approximately 24 months
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