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A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma

NCT04220307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a single-arm, open-label, multicenter, phase II study to evaluate the anti-tumor activity, PK and immunogenicity of AK104 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

AK104

Subjects will receive AK104 by intravenous administration

Sponsors & Collaborators

  • Akeso Pharmaceuticals, Inc.

    collaborator OTHER

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Ruihua Xu, MD · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-26
Primary Completion
2021-05-15
Completion
2023-03-09

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220307 on ClinicalTrials.gov