Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-06 @ 7:31 PM
Study NCT ID:
NCT03866967
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2019-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma
Sponsor:
Akeso
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: