A Phase 1b, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Patients with Dose Limiting Toxicities
研究概览
简要总结
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.
详细描述
This is a Phase 1b, open-label study to investigate the use of LS301-IT (investigational medicinal product [IMP]), a fluorescence imaging agent used for visualization of tumor margins and other suspicious nodules in patients with primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
Up to 24 patients (4 dose cohorts, up to 6 patients each) for Phase 1b study (total of 24 patients maximum). There will be no stratification by dosing interval or lung cancer type (e.g., lung adenocarcinoma, lung squamous cell carcinoma).
As safety is the primary objective of this study, the safety of each dose level will be assessed by the Safety Review Committee (SRC). Based upon the safety results of the first cohort, the SRC will recommend to the Sponsor which dose levels of LS301-IT may be administered in subsequent cohorts.
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
- Single (Outcomes Assessor)
盲法说明
The pathologist evaluating the biopsy samples will be blinded as to patient participation in the study.
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
- •ECOG performance status of 0 to 2
- •Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
- •Are scheduled to undergo surgical thoracoscopy and resection of the lung.
排除标准
- •Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
- •No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery
- •History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
- •Known sensitivity to near infrared light
- •Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
- •History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) > 470 ms
研究组 & 干预措施
LS301-IT Cohort 3
0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
干预措施: LS301-IT (Drug)
LS301-IT Cohort -1
0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
干预措施: LS301-IT (Drug)
LS301-IT Cohort 1
0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
干预措施: LS301-IT (Drug)
LS301-IT Cohort 2
0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
干预措施: LS301-IT (Drug)
结局指标
主要结局
Number of Patients with Dose Limiting Toxicities
时间窗: 2 to 7 days after dosing
Dose Limiting Toxicity - Any CTCAE Grade 2, 3, 4, or 5 AE (any treatment emergent sign or symptom) at least possibly related to IMP will be considered a DLT, as well as any other AE deemed clinically relevant by the SRC.
Number of Patients that discontinue the study or have their surgery cancelled due to toxicity
时间窗: From start of dosing to time of surgery
Treatment discontinuation and/or surgery cancellation due to toxicity (hypersensitivity reaction to LS301-IT)
次要结局
未报告次要终点