A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Blood pressure (mmHg)
研究概览
简要总结
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
- To establish the dose of TRK-950 recommended for future phase 2 studies
详细描述
This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.
Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.
In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
- •Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
- •Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
- •Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
- •Measurable disease per RECIST 1.1 (primary or metastases)
排除标准
- •New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Pregnant or nursing women
- •Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
- •Unwillingness or inability to comply with procedures required in this protocol
- •Known active infection with HIV, hepatitis B, hepatitis C
- •Symptomatic brain metastases
- •Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •Patients who are currently receiving any other investigational agent
研究组 & 干预措施
Arm 1 - TRK-950
- Solid tumor
- TRK-950 (Three dose levels will be explored during Arm 1)
干预措施: TRK-950 (Biological)
Arm 2 - TRK-950
- Colon cancer
- TRK-950 (Low dose and High dose)
干预措施: TRK-950 (Biological)
Arm 3 -TRK-950
- Cholangiocarcinomas
- TRK-950 (Low dose)
干预措施: TRK-950 (Biological)
结局指标
主要结局
Blood pressure (mmHg)
时间窗: through study completion, an average of 1 year
Weight (lbs/kg)
时间窗: through study completion, an average of 1 year
Temperature (°F or °C)
时间窗: through study completion, an average of 1 year
Electrocardiogram
时间窗: through study completion, an average of 1 year
Adverse event
时间窗: through study completion, an average of 1 year
Respiratory rate (bpm)
时间窗: through study completion, an average of 1 year
CTCAE version 4.03
时间窗: through study completion, an average of 1 year
Heart rate (bpm)
时间窗: through study completion, an average of 1 year
Height (inches/cm)
时间窗: through study completion, an average of 1 year
Karnofsky performance status
时间窗: through study completion, an average of 1 year
Clinical laboratory tests
时间窗: through study completion, an average of 1 year
次要结局
- Apparent volume of distribution(Vd)(through study completion, an average of 1 year)
- Tumor response rate(through study completion, an average of 1 year)
- Time to progression(through study completion, an average of 1 year)
- Progression free survival(through study completion, an average of 1 year)
- Terminal elimination half life(t1/2)(through study completion, an average of 1 year)
- Total body clearance(CL)(through study completion, an average of 1 year)
- Time to maximum plasma concentration(Tmax)(through study completion, an average of 1 year)
- Area under the concentration curve(AUC)(through study completion, an average of 1 year)
- Maximum plasma concentration(Cmax)(through study completion, an average of 1 year)
- Duration of response(through study completion, an average of 1 year)