A Phase IB, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of Pemefolacianine for Intraoperative Molecular Imaging of Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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 Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
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
- 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
- •Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
- •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 or open surgery (thoracotomy) and resection of the lung.
- •If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
- •Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
排除标准
- •Contraindications for surgery or any medical condition that in the opinion of the investigator could significantly 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 (e.g., Cytalux)
- •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 fluorescent 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
- •History of radiation therapy to the chest
- •Received a systemic investigational drug of any kind for any indication within 4 weeks or 5 half-lives prior to administration of Pemefolacianine for Injection and/or the patient has received Pemefolacianine for Injection previously
- •Total bilirubin level >1.5 times upper limit of normal at screening
- •Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 times the upper limit of normal (ULN) at screening
- •The patient is pregnant, breast feeding, or plans to become pregnant within 6 months of the administration of Pemefolacianine for Injection or has a positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
研究组 & 干预措施
Pemefolacianine Cohort 1
The dose of Pemefolacianine for Injection planned to be administered to the first cohort of patients is 0.02 mg/kg.
干预措施: Pemefolacianine Cohort 1 in Part A (Drug)
Pemefolacianine Cohort 2
The patients in second cohort were planned to receive dose Pemefolacianine for Injection at 0.04 mg/kg.
干预措施: Pemefolacianin Cohort 2 in Part B (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: Day 1 through Day 30
Safety of Pemefolacianine for Injection, as assessed by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant changes in laboratory values, vital signs, physical examinations, and electrocardiograms (ECGs) from baseline through the end of the study.
次要结局
- Signal-to-Background Ratio in Intraoperative Tissue Images(Day 2 surgery)
研究者
Sunil Singhal
Chief, Division of Thoracic Surgery
Abramson Cancer Center at Penn Medicine