An Open-Label, Phase II Study to Evaluate SCB01A in Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Received Platinum-Based Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
To evaluate the safety and efficacy of SCB01A in head and neck cancer.
详细描述
The study is designed to evaluate the safety and efficacy of SCB01A in patients with recurrent or metastatic squamous cell carcinoma in head and neck.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed squamous cell carcinoma of head and neck
- •Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.
- •At least one measurable tumor lesion according to RECIST
- •Suitable Eastern Cooperative Oncology Group (ECOG) performance status
- •All eligible patients of childbearing potential have to use effective contraception
- •Signed informed consent before enrolment
排除标准
- •Receiving Chemotherapy, radiation therapy, major surgery or investigational agents
- •Severe pulmonary obstructive or restrictive disease
- •Uncontrolled inflammatory disease
- •Clinically significant cardiac disease
- •Results of laboratory tests
- •Pregnancy or nursing status
- •Known hypersensitivity to any component of SCB01A
- •History of exposure to SCB01A or its analogues
- •History of malignancy other than head and neck cancer
- •History of active or significant neurological disorder or psychiatric disorder
- •Any other reason the investigator deems the patient to be unsuitable for the study
研究组 & 干预措施
SCB01A
This study is a single arm, open-label, Phase II trial
干预措施: SCB01A (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: 9 weeks from 1st administrationm drug
To assess the DCR (=complete response (CR) + partial response (PR) + stable disease (SD)) at the end of the 9th week (3 cycles, each cycle consisted of 21 days) after treatment with SCB01A, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sumdiameterswhile on study.
次要结局
- To Assess the Overall Survival Rate(an expected average of 36 weeks)
- To Assess the Progression-free Survival According to RECIST v.1.1(an expected average of 12 weeks)