Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Safety - The Number of Patients With ALM-488 Related Adverse Events
研究概览
简要总结
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
详细描述
This study will evaluate the safety, tolerability, and efficacy of Bevonescein (ALM-488) administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of Bevonescein (ALM-488) in this subject population and determine the dose of Bevonescein (ALM-488) needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of Bevonescein (ALM-488) administration, relative to surgery, on fluorescence characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •A neoplasm located in the head and neck.
- •Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
- •Can understand and is willing to sign a written informed consent document.
- •≥18 years of age.
- •Life expectancy of at least 6 months.
- •Normal liver and kidney functions.
- •If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence.
- •Plans to undergo head and neck surgery.
排除标准
- •Prior radiation or chemotherapy for any prior head and neck neoplasm.
- •Open surgery in the ipsilateral head and neck within 1 year.
- •Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
- •Current evidence of renal disease.
- •Pregnant or breastfeeding.
- •Unresolved acute toxicity from prior anti-cancer therapy.
- •History of fluorescein allergy.
- •Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.
研究组 & 干预措施
Dose Escalation/De-Escalation Cohorts
This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488).
干预措施: Bevonescein (Drug)
Dose Timing Cohorts
This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488).
干预措施: Bevonescein (Drug)
结局指标
主要结局
Safety - The Number of Patients With ALM-488 Related Adverse Events
时间窗: 28 (+5) days
The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
未报告次要终点