Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response Rate (RR)
研究概览
简要总结
The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.
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
- •Patient with male or female aged ≥ 20 (and aged < 75 in Phase 1 part)
- •Patients whose malignant pleural mesothelioma was histologically confirmed
- •Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized
- •Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less
排除标准
- •Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored
- •Patients with tumor lesions in central nervous system confirmed in MRI or CT
研究组 & 干预措施
YS110
Phase 1 part: Administration of 3 different dose cohort
Phase 2 part: Administration of recommended dose determined from result of Phase 1 part
干预措施: YS110 (Drug)
结局指标
主要结局
Response Rate (RR)
时间窗: Assessed for duration of study participation which is estimated to be 18 months
The proportion of subjects with assessed the best overall response as CR or PR
EORTC QLQ-C30
时间窗: Assessed for duration of study participation which is estimated to be 18 months
Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients
LCSS-Meso
时间窗: Assessed for duration of study participation which is estimated to be 18 months
Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma
Status of onset of Dose Limiting Toxicity (DLT)
时间窗: 18 days
Assessed by number of subjects with DLT of YS110
Disease Control Rate (DCR)
时间窗: 6 months
The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Progression Free Survival (PFS)
时间窗: Assessed for duration of study participation which is estimated to be 18 months
The period from the starting day of the administration to Progressive Disease (PD) or death
Overall Survival (OS)
时间窗: Assessed for duration of study participation which is estimated to be 18 months
The period from the starting day of the administration to death
次要结局
未报告次要终点