KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 59
- 主要终点
- Objective response
研究概览
简要总结
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Female subjects with age 18 to 70 (inclusive) years at the time of consent
- •LVEF ≥50% at baseline
- •ECOG performance status of 0-1
- •Have not received 1L treatment for recurrent or metastatic breast cancer
- •Adequate organ function
排除标准
- •History of exposure to the cumulative doses of doxorubicin > 400 mg / m2 or equivalent
- •History of autoimmune diseases
- •Active brain metastasis
- •Concurrent diseases that compromise patient's safety
研究组 & 干预措施
KN035 in combination with trastuzumab and docetaxel
干预措施: KN035 (Biological)
KN035 in combination with trastuzumab and docetaxel
干预措施: Trastuzumab (Biological)
KN035 in combination with trastuzumab and docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Objective response
时间窗: 12 months
To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer. • Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator
次要结局
- Adverse events(12 months)
研究者
JZhao
Doctor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University