NCT05508334已完成1 期
An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- RP2D
研究概览
简要总结
The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies
详细描述
The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must be ≥ 18 years at the first screening examination / visit.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Life expectancy of at least 12 weeks
- •Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors;
- •Phase II-Advanced malignant solid tumor with MSLN expression
- •Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria
- •Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory.
- •Adequate organ function
- •Voluntarily sign an informed consent form
排除标准
- •Cancer metastases in the brain
- •Active infection or past hepatitis B or C infection
- •Major surgery less than 1 month before the start of the study
- •Uncontrolled heart disease
- •History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
研究组 & 干预措施
Experimental: RC88
Experimental
Subjects will receive intravenous infusion of RC88 once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs
干预措施: RC88 (Drug)
结局指标
主要结局
RP2D
时间窗: 28 days after first treatment
Incidence of DLT (dose limiting toxicity) of RC88
次要结局
- Objective Response Rate (ORR)(24 months)
- Maximum Concentration (Cmax) of RC88(pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours)
- Terminal Half Life (t1/2) of RC88(pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours)
- Progression Free Survival (PFS)(24 months)
研究者
研究点 (2)
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