drugset / Trial / NCT07371208
Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.
Timeline
- Start
- 2025-12-24
- Primary completion
- 2028-08
- Completion
- 2030-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 2 unknown | — |
| Subject | KL-A167 | Unknown | 900 mg | — |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 5 mg/kg | — |