This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
The main purpose of this study is to assess the safety and tolerability of SHR-1701 in patients with R/M NPC. The secondary purpose is to assess the anti-tumor activity and immunogenicity of SHR-1701 in R/M NPC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Maximum 6 cycles for combined therapy.
Maximum 6 cycles for combined therapy.
Cancer Hospital of Guangzhou Sun Yat-sen University
Guangzhou, Guangdong, China
Toxicity Toxicity
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: up to 2 years
Objective Response Rate (ORR) per RECIST 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: up to 2 years
Progression-free Survival (PFS) per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Disease Control Rate (DCR) per RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Time frame: up to 2 years
Immunogenicity of SHR-1701
anti SHR-1603 antibodies (ADA)
Time frame: up to 2 years
Overall Survival (OS)
Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier.
Time frame: up to 2 years
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Maximum 6 cycles for combined therapy.