A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients with advanced tumors. CPI-200 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD)
详细描述
Primary Objectives:
• To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors
Secondary Objectives:
- To evaluate the pharmacokinetics (PK) of CPI-200
- To evaluate clinical response and resolution of symptoms after CPI-200 treatment
- To characterize adverse events of CPI-200 in patients with advanced cancers
Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-200 within 21 days:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Males and females
- •Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
- •Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
- •Have an ECOG performance status of 0-1
- •Have a life expectancy of at least 12 weeks (in the opinion of the investigator)
- •Have adequate bone marrow reserve, liver and renal function
- •Be reasonably recovered from preceding major surgery and no major surgery within 4 weeks prior to the start of Day 1 treatment
- •Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
- •Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 3 months after the last day of treatment
排除标准
- •Have peripheral sensory neuropathy of Grade 2 or greater at screening
- •Have known hypersensitivity to chemotherapeutic agents
- •Have thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe
- •Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
- •Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment
- •Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
- •Have experienced any of the following within the 6-month period prior to screening: unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%
- •Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
- •Is pregnant or breast-feeding
研究组 & 干预措施
CPI-200
Dose Escalation Group: CPI-200 will be administered via intravenous infusion once every 3 weeks for up to 7 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design
Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group
干预措施: CPI-200 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 21 days
• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE
次要结局
- Rate of Adverse Effect(through study completion, an average of 4 months)
- Area Under the Curve (AUC)(8 Days)
- Maximum Plasma Concentration (Cmax)(8 Days)
- Rate of Clinical Benefit(through study completion, an average of 4 months)