Trials / Completed
CompletedNCT04380805
A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer
A Phase 2, Multicenter, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of AK104 in Subjects With Recurrent or Metastatic Cervical Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Akeso · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2022-12-22
- Completion
- 2023-01-31
- First posted
- 2020-05-08
- Last updated
- 2025-02-28
Locations
25 sites across 3 countries: United States, Australia, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04380805. Inclusion in this directory is not an endorsement.