drugset / Trial / NCT07258108
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
Phase 2
Recruiting
35 enrolled
Sun Yat-sen University
Fifth Affiliated Hospital, Sun Yat-Sen University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor. The primary endpoint is the 6-month PFS rate. Treatment will continue until disease progression or intolerable toxicity, with periodic imaging assessments and survival follow-up.
Timeline
- Start
- 2025-11-13
- Primary completion
- 2027-07-30
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lucanisatuzumab | Unknown | 5 mg/kg | Intravenous |
| Subject | tagolimumab | Unknown | 900 mg | Intravenous |