NCT04282070

SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).

Detailed description

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-1701	Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
DRUG	Gemcitabine	Maximum 6 cycles for combined therapy.
DRUG	Cisplatin	Maximum 6 cycles for combined therapy.
DRUG	Albumin Paclitaxel	Maximum 6 cycles for combined therapy.

Timeline

• Start date: 2020-03-27
• Primary completion: 2022-04-16
• Completion: 2022-12-15
• First posted: 2020-02-24
• Last updated: 2021-12-21

Locations

1 site across 1 country: China