A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Duration of response (DOR)
研究概览
简要总结
This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
详细描述
The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.
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 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 HER2 positive solid tumor
- •Received at least one prior standard therapy
- •At least one measurable 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
- •Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids)
- •Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
- •Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
- •Severe chronic and active infection, need to system antibiosis/antiviral treatment
- •Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management
- •Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
结局指标
主要结局
Duration of response (DOR)
时间窗: up to 2 years
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Dose-limiting toxicity（DLT）
时间窗: 28 days
Dose-limiting toxicity
Objective response rate (ORR)
时间窗: up to 2 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
次要结局
- Progression free survival (PFS) rates(6 months and 12 months)
- Clinical benefit rate(up to 2 years)
- Overall survival (OS) rates(6 months and 12 months)
研究者
Shen Lin
MD,Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital
Peking University