drugset / Trial / NCT06202313
Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) plus Eribulin compared to the efficacy and safety of Eribulin monotherapy in the treatment of adult patients with recurrent, or metastatic triple negative breast cancer. The primary study hypothes is that the combination of Cadonilimab (AK104) plus Eribulin is superior to Eribulin monotherapy with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator.
Timeline
- Start
- 2024-02-10
- Primary completion
- 2025-12-30
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cadonilimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |