Status and phase
Conditions
Treatments
About
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.
Full description
Primary objective: To evaluate BICR-based objective response rate (ORR) and overall survival (OS) benefit of BL-B01D1 versus physician's choice of chemotherapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Voluntarily sign the informed consent and follow the requirements of the protocol.
No gender limit.
Age ≥18 years old.
expected survival time ≥3 months.
Patients with histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma treated with PD-1/PD-L1 monoclonal antibody after failure of at least two lines of chemotherapy (at least one line of platinum-based).
Patients who are suitable for the final line treatment with the control chemotherapy drugs specified in this protocol.
Must have at least one measurable lesion according to RECIST v1.1 definition;
ECOG 0 or 1.
Toxicity from previous antineoplastic therapy has returned to grade 1 or less as defined in NCI-CTCAE v5.0 (except alopecia, fatigue, hyperpigmentation, hormone-replacement stable hypothyroidism, grade 2 peripheral neurotoxicity after chemotherapy, or other eligibility criteria).
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.
No blood transfusion, no use of cell growth factors and/or platelet-raising agents within 14 days prior to the first dose of study drug, and organ function levels that meet the following criteria:
Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT)≤1.5×ULN.
Urine protein ≤2+ or < 1000mg/24h.
For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
368 participants in 2 patient groups
Loading...
Central trial contact
Sa Xiao, PHD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal