Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.
详细描述
The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed inform consent form(ICF)
- •Age ≥ 18 years and ≤ 75 years, male or female
- •Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ & ISH+ HER2 expressing: IHC2+ & ISH- or IHC 1+ & ISH+
- •Received at least one prior standard therapy
- •At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
- •LVEF≥ 50% (ECHO)
- •Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
- •Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures
排除标准
- •Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- •Accepted radiotherapy within 4 weeks before enrollment
- •An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
- •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
- •Severe chronic and active infection, need to system antibiosis/antiviral treatment
- •Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
- •Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
研究组 & 干预措施
HER2 overexpression
HER2 IHC 3+ or IHC2+ and ISH+
干预措施: KN026 10 mg/kg QW (Drug)
HER2 overexpression
HER2 IHC 3+ or IHC2+ and ISH+
干预措施: KN026 20 mg/kg Q2W (Drug)
HER2 overexpression
HER2 IHC 3+ or IHC2+ and ISH+
干预措施: KN026 30 mg/kg Q3W (Drug)
HER2 expression
HER2 IHC 2+ISH- or IHC 1+ and ISH+
干预措施: KN026 10 mg/kg QW (Drug)
HER2 expression
HER2 IHC 2+ISH- or IHC 1+ and ISH+
干预措施: KN026 20 mg/kg Q2W (Drug)
HER2 expression
HER2 IHC 2+ISH- or IHC 1+ and ISH+
干预措施: KN026 30 mg/kg Q3W (Drug)
结局指标
主要结局
ORR
时间窗: 1 years
clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria
DOR
时间窗: 1 years
clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
次要结局
未报告次要终点