A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.
详细描述
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Fully understand this study and voluntarily sign ICF;
- •18 to 75 years old (including 18 and 75 years old), male or female;
- •Subjects with advanced solid tumors, including:
- •Phase I study:
- •subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
排除标准
- •Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included;
- •Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- •Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter;
- •Human immunodeficiency virus (HIV) antibody positive;
- •Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;
- •Lactating women. If they are willing to stop breastfeeding, they can also be included in this study.
研究组 & 干预措施
Endometrial cancer
Endometrial cancer
干预措施: CS1001 (Drug)
Cholangiocarcinoma
Cholangiocarcinoma
干预措施: Donafenib (Drug)
Cholangiocarcinoma
Cholangiocarcinoma
干预措施: CS1001 (Drug)
Squamous cell carcinoma of the head and neck
Squamous cell carcinoma of the head and neck（HNSCC）
干预措施: Donafenib (Drug)
Squamous cell carcinoma of the head and neck
Squamous cell carcinoma of the head and neck（HNSCC）
干预措施: CS1001 (Drug)
Endometrial cancer
Endometrial cancer
干预措施: Donafenib (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From the day of first dose to 21 days after last dose
To determine the dose limiting toxicity (DLT)
时间窗: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the maximum tolerated dose(MTD)
时间窗: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the recommended dose of phase II
时间窗: In the dose escalation part, from the day of first dose to 21 days after last dose
Objective response rate as determined by the Invertigator using RECIST V1.1
时间窗: In the dose escalation part, from the day of first dose to 21 days after last dose
次要结局
- Anti-CS1001 antibody(From the day of first dose to 21 days after last dose)
- Objective response rate (ORR)(From the day of first dose to 21 days after last dose)
- Overall survival(OS)(From the day of first dose to 21 days after last dose)
- Progression free survival(PFS)(From the day of first dose to 21 days after last dose)
- Duration of remission (DOR)(From the day of first dose to 21 days after last dose)