NCT07371208

Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	SKB264	1\) Neoadjuvant Treatment Phase Phase a: All eligible subjects will receive Sac-TMT (5 mg/kg, Day 1, every 2 weeks) combined with KL-A167 (900 mg, Day 1, every 2 weeks) for 6 cycles (12 weeks). At Week 12 (beginning of Week 13), radiographic assessment via contrast-enhanced breast MRI will be performed. Based on tumor response, patients proceed to Neoadjuvant Phase b: i. Responders (investigator-assessed Partial Response \[PR\] or Complete Response \[CR\]): Continue the same combination regimen for an additional 12 weeks of neoadjuvant therapy. ii. Non-responders (investigator-assessed Stable Disease \[SD\] or Progressive Disease \[PD\]): Switch to KL-A167 (900 mg every 2 weeks) combined with nab-paclitaxel (100 mg/m², Days 1, 8, 15, every 4 weeks per cycle) and carboplatin (AUC 2 mg·min/mL, Days 1, 8, 15, every 4 weeks per cycle) for 12 weeks.

Timeline

• Start date: 2025-12-24
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: China