Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- dose-limiting toxicity KN046
研究概览
简要总结
This is an open-label, phase II study of KN046 combined with chemotherapy and palliative radiotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma to evaluate the safety, efficacy and tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment
- •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
- •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
- •Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.
- •Patients who are participating or have 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 for treatment.
- •Patients who have 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 Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
- •Known HIV infection or known history of acquired immune deficient syndrome (AIDS)
- •Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for 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
Concurrent chemoradiotherapy and KN046
Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
干预措施: palliative radiotherapy (Radiation)
Concurrent chemoradiotherapy and KN046
Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
干预措施: KN046 (Drug)
chemoradiotherapy and sequential KN046
Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
干预措施: palliative radiotherapy (Radiation)
chemoradiotherapy and sequential KN046
Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
干预措施: KN046 (Drug)
结局指标
主要结局
dose-limiting toxicity KN046
时间窗: 28 days after first dose
6-month progression free survival rate assessed by investigator based on RECIST 1.1
时间窗: 6 months after first dose
Objective response rate assessed by investigator based on RECIST 1.1
时间窗: 2 years
次要结局
未报告次要终点
研究者
Xiaolong Fu
Director, Department of Radiation Oncology
Shanghai Chest Hospital