This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with chemotherapy, followed by maintenance therapy with PD-1 monoclonal antibody with or without BL-B01D1, as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Age ≥ 18 years;
Expected survival time ≥ 3 months;
Trial participants with nasopharyngeal carcinoma confirmed by histopathology and/or cytology, either initially diagnosed with metastatic disease or relapsed after curative-intent treatment;
Trial participants who have received prior systemic therapy;
Those who have received prior therapy targeting the mechanism of tumor immuno-oncology;
Those who have previously received antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, or EGFR- and/or HER3-targeting antibodies/ADCs;
Trial participants who have received systemic immunostimulatory agents within 4 weeks prior to the first dose;
Parallel
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
PD-1 monoclonal antibody
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
cisplatin
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
gemcitabine
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
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.
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
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.
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.
Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
