A phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who had failed at least two lines of platinum-based chemotherapy after receiving PD-1/PD-L1 monoclonal antibody as the last line of therapy.
Primary objective: To evaluate BICR-based objective response rate (ORR) and overall survival (OS) benefit of BL-B01D1 versus physician's choice of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
386
Administration by intravenous infusion
Oral administration
Administration by intravenous infusion
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Time frame: Up to approximately 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BIRC was 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
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
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.
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Administration by intravenous infusion
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
T1/2
Half-life (T1/2) of BL-B01D1 will be investigated.
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