This study is the first human study of Toripalimab injection(subcutaneous) .Patients with advanced nasopharyngeal carcinoma were planned to be enrolled.~Two cohorts were initially proposed, Toripalimab injection (subcutaneous) Q3W combination with gemcitabine and cisplatin (GP) regimen and JS001sc long-term dosing combined with GP regimen.~Cohort 1: JS001sc Q3W SC combined with GP regimen chemotherapy; Cohort 2: JS001sc long period SC combined with GP regimen chemotherapy; IV cohort (if applicable): the Safety Monitor Committe (SMC) will discuss whether to conduct an IV cohort and determine the dose/frequency of the IV cohort, based on the initial safety and clinical pharmacological data of triprilimab injection in combination with the GP regimen; Additional cohort (if applicable): the exploration of additional dosing/frequency will be discussed by the SMC based on prior safety and clinical pharmacological data.~Subjects with no disease progression (PD) after the combination chemotherapy period (JS001/JS001SC combined with GP regimen, in one therapeutic cycle of three weeks, for at most 6 cycles) will enter the monotherapy maintenance period.JS001/JS001sc monotherapy maintenance treatment of the same dose/frequency f the combination chemotherapy period.Based on the preliminary safety and clinical pharmacological data, SMC will discusses whether to change the dose/frequency.
The purpose of this phase I clinical study was to evaluate the safety and tolerability of JS001sc monotherapy and combination with gemcitabine and cisplatin (GP) in patients with Advanced nasopharyngeal carcinoma.