NCT05751486

A Clinical Study to Evaluate the Safety and Tolerability of JS001sc in Advanced Nasopharyngeal Carcinoma

A Randomised, Open-label, Phase I Dose Exploration Study to Compare Single, Multiple, and Long-term Dosing of Toripalimab Injection (Subcutaneous) With Toripalimab Injection (IV) in Patients With Advanced Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Toripalimab injection(subcutaneous)/JS001sc	JS001sc Q3W combination with gemcitabine and cisplatin.
BIOLOGICAL	Toripalimab injection(subcutaneous)/JS001sc	JS001sc long period combination with gemcitabine and cisplatin.
BIOLOGICAL	Toripalimab /JS001	JS001 IV (if applicable) .
BIOLOGICAL	Toripalimab injection(subcutaneous)/JS001sc	Additional cohort (if applicable)

Timeline

• Start date: 2022-10-21
• Primary completion: 2023-12-30
• Completion: 2025-12-30
• First posted: 2023-03-02
• Last updated: 2023-03-02

Locations

1 site across 1 country: China