MedTrace Logo

A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer

NCT04380805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-28

No results posted yet for this study

Summary

This is a Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.

Conditions

  • Recurrent Cervical Cancer
  • Metastatic Cervical Cancer

Interventions

BIOLOGICAL

AK104

All subjects will receive AK104 as a single agent at a dose of 6 mg/kg Q2W (Day 1 and Day 15 of each 28 day treatment cycle) via IV infusion.

Sponsors & Collaborators

  • Akesobio Australia Pty Ltd

    collaborator INDUSTRY

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Leslie Randall, MD · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2022-12-22
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

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 NCT04380805 on ClinicalTrials.gov