An Open-Label, Multicenter, Dose-Escalation and Expansion Phase Ia/Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KN046 Monotherapy in Subjects With Advanced Solid Tumors and Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 12
- 主要终点
- In the dose expansion part, Duration of response (DoR).
研究概览
简要总结
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent; willing and able to complete all required procedures of study.
- •With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- •Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
- •ECOG performance status of 0 or
- •Subject must have adequate organ function.
- •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 PK sample collection and the required study follow-up procedures.
排除标准
- •Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- •Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
- •Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- •Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
- •Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- •Active HBV or HCV infection.
- •Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
- •Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
- •Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
研究组 & 干预措施
KN046
干预措施: KN046 (Drug)
结局指标
主要结局
In the dose expansion part, Duration of response (DoR).
时间窗: up to 2 years.
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first.
In the dose escalation part, number of participants with dose limiting toxicity (DLT).
时间窗: During the first 4 weeks of treatment.
In the dose expansion part,Objective response rate (ORR).
时间窗: up to 2 years.
Objective response is defined as complete response (CR) or partial response (PR)
次要结局
未报告次要终点