drugset / Trial / NCT07533123
A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC). To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Timeline
- Start
- 2026-03-17
- Primary completion
- 2029-03-17
- Completion
- 2030-03-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | JSKN016 | Unknown | 6 mg/kg | Intravenous |
| Comparator | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |