A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.
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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female subject >= 18 years;
- •Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive;
- •Adequate organ function assessed within 7 days prior to first trial treatment
- •ECOG score 0 or 1;
- •Left ventricular ejection fraction (LVEF) ≥ 50% at baseline;
- •Life expectancy >3 months
排除标准
- •Untreated active CNS metastasis or leptomeningeal metastasis;
- •Uncontrolled tumor-related pain;
- •Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment;
- •Major surgery for any reason within 28 days;
- •Curative radiation within 3 months of the first dose of trial treatment;
- •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
parallel-group expansion Phase
KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )
干预措施: KN026 combined with Palbociclib and Fulvestrant (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: up to 24 weeks
The proportion of patients experiencing dose limiting toxicities
Objective response rate (ORR)
时间窗: through study completion, an average of 1 year
ORR as assessed by the investigator according to RECIST 1.1
次要结局
- Progression free survival (PFS) rates(6 months and 12 months)
- Clinical benefit rate (CBR)(CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks)
- Duration of response (DOR)(through study completion, an average of 1 year)
- Overall survival (OS)(6 months and 12 months)