Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
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.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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/cytologically confirmed, locally advanced unresectable or metastatic breast cancer
- •ECOG score 0 or 1
- •Life expectancy >3 months
- •According to the definition of RECIST1.1, the patient has at least one measurable lesion
- •Adequate organ function prior to start treatment with KN026
- •Able to understand, voluntarily participate and willing to sign the ICF
排除标准
- •Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- •Accepted radiotherapy within 4 weeks before enrollment
- •Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
- •Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
- •History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
- •History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
- •Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
研究组 & 干预措施
Concurrent chemotherapy and KN026
KN026 combined with docetaxol
干预措施: Concurrent chemotherapy and KN026 (Drug)
KN026 monotherapy
KN026 monotherapy
干预措施: KN026 monotherapy (Drug)
A combination treatment of KN026 and KN046
KN026 combined with KN046
干预措施: KN026 combination (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Throughout the duration of the study; up to 2 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Duration of response (DOR)
时间窗: up to 2 years
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
次要结局
- durable benefit rate (DBR)(DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks)
- Progression free survival (PFS) rates(6 months and 12 months)
- Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest(Throughout the duration of the study)
- Overall survival (OS) rates(6 months and 12 months)