This is a multicenter, single-arm open-label, phase II study to evaluate the anti-tumor activity, safety, PK and immunogenicity of AK105 (Anti-PD1 antibody) in patients with metastatic nasopharyngeal carcinoma who have progressed after at least 2 prior lines of systemic chemotherapy (of which one of them must be platinum-based chemotherapy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
intravenous (IV) infusion
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Objective response rate (ORR) assessed by IRRC per RECIST v1.1 for anti-tumor activity in the Full Analysis Set (FAS) population
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame: up to 2 years
Progression-free survival (PFS) as assessed by IRRC and investigator
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first).
Time frame: up to 2 years
Disease control rate (DCR) as assessed by IRRC and investigator
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Time frame: up to 2 years
Duration of response (DoR) as assessed by IRRC and investigator
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Overall survival (OS)
OS is defined as the time from the date of randomization to death from any cause.
Time frame: up to 2 years
Incidence and severity of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product.
Time frame: From the time of informed consent signed through 90 days after last dose of AK105
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Observed concentrations of AK105
The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
Time frame: From first dose of AK105 through 90 days after last dose of AK105
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Time frame: From first dose of AK105 through 90 days after last dose of AK105
ORR as assessed by investigator per RECIST v1.1 for anti-tumor activity in the FAS population
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame: up to 2 years
Time to response (TTR) assessed by IRRC and investigator ;
TTR is defined as the time from the first dose of study drug to the first documented response (CR or PR).
Time frame: up to 2 years