NCT03866967

A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma

A Single-arm, Open-label, Multicenter Phase II Clinical Study of AK105 in Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Second and Subsequent Lines of Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AK105	intravenous (IV) infusion

Timeline

• Start date: 2019-03-27
• Primary completion: 2021-03-13
• Completion: 2024-03-22
• First posted: 2019-03-07
• Last updated: 2025-02-27

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study