RecruitingPhase 2NCT07371208

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

40 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two experimental drugs — sacituzumab tirumotecan (an antibody-drug conjugate) and KL-A167 (an immunotherapy) — as a pre-surgery treatment for people with triple-negative breast cancer (a type of breast cancer that doesn't respond to hormone or HER2 therapies). **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with triple-negative breast cancer with a tumor at least 2 cm in size and no distant spread - You have not yet received any treatment for your breast cancer - You are in good physical condition (ECOG 0 or 1) - Your blood counts, liver, kidney, and heart function meet required levels **You may NOT be eligible if...** - You have inflammatory breast cancer - You have only skin lesions or bone lesions (no other measurable tumor) - You have previously received chemotherapy or immunotherapy for breast cancer - You are pregnant or breastfeeding - You have a serious heart condition or active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB264

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.