Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Adverse events related to ABY-029
研究概览
简要总结
The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach head and neck squamous cell carcinomas (HNSCC) so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Preoperative diagnosis of head and neck squamous cell carcinoma with planned surgical resection of the oral cavity, oropharynx, larynx, or hypopharynx.
- •Tumor judged to be operable.
- •Valid informed consent by participant.
- •Age ≥ 18 years old.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with a medical history of (Grade 2 or higher) hepatic/renal function compromise.
- •Individuals who are pregnant or breast feeding.
- •Patients on experimental or approved anti-EGFR targeted therapies.
研究组 & 干预措施
ABY-029 6X dose group
ABY-029 will be administered at the 6X dose level prior to surgery to participants with HNSCC.
To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
干预措施: ABY-029 (Drug)
ABY-029 10X dose group
ABY-029 will be administered at the 10X dose level prior to surgery to participants with HNSCC.
To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
干预措施: ABY-029 (Drug)
结局指标
主要结局
Adverse events related to ABY-029
时间窗: one month
To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens
时间窗: up to three months
To measure the diagnostic performance of ABY-029, the diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens histologically confirmed as tumor from participants receiving the 6X microdose and 10X microdose.
次要结局
未报告次要终点
研究者
Joseph A. Paydarfar
Principal Investigator
Dartmouth-Hitchcock Medical Center