Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2-positive Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- tp CR as assessed by local pathologist
研究概览
简要总结
This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.
详细描述
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject >= 18 years;
- •Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);
- •Early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) breast cancer;
- •Adequate organ function assessed within 7 days prior to first trial treatment;
- •ECOG score 0 or 1;
- •Left ventricular ejection fraction (LVEF) ≥ 55% at baseline;
排除标准
- •Stage IV (metastatic) breast cancer;
- •Inflammatory breast cancer;
- •Previous anti-cancer therapy or radiotherapy for any malignancy;
- •Major surgery for any reason within 28 days;
- •History of uncontrolled intercurrent illness;
- •Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
研究组 & 干预措施
KN026 + Docetaxel
KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles
干预措施: KN026 (Drug)
结局指标
主要结局
tp CR as assessed by local pathologist
时间窗: up to 12 weeks
total pathological complete response as assessed by local pathologist
次要结局
- bp CR as assessed by local pathologist(up to 12 weeks)
- ORR as assessed by the investigator according to RECIST 1.1(up to 12 weeks)
- safety as assessed by the investigator according to RECIST 1.1(up to 12 weeks)