drugset / Trial / NCT06202313

Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

NCT06202313

Phase 2 Not yet recruiting 128 enrolled Shengjing Hospital
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

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 10 mg/kg Intravenous
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous