A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma
NCT03866967 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-02-27
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
- BIOLOGICAL
-
AK105
intravenous (IV) infusion
Sponsors & Collaborators
-
Akeso Tiancheng, Inc
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Chaosu Hu, MD · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-27
- Primary Completion
- 2021-03-13
- Completion
- 2024-03-22
- FDA Drug
- Yes
Countries
- China
Study Locations
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