An Open-label Study to Investigate the Tolerability, Pharmacokinetics and Anti-tumour Effect Following Photodynamic Therapy (PDT) With Single-ascending Doses of LUZ11 in Patients With Advanced Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 发起方
- Luzitin SA
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.
详细描述
LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients.
The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Written informed consent
- •Men or non-pregnant, non-breast feeding women
- •Karnofsky performance status of 60% or greater
- •Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck
- •Clearly visible tumor on the oral cavity or cutaneous surface
排除标准
- •Known hypersensitivity to any of the formulation ingredients
- •Known hypersensitivity to porphyrins
- •Porphyria or other diseases exacerbated by light
- •Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site
- •Planned skin phototherapy session(s) within the study timeframe
- •Planned surgical procedure within the study timeframe
- •Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe
- •Existing therapy with a photosensitizing agent
- •Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening
- •Myocardial infarction within 6 months prior to screening
- •Contraindication to MRI with gadolinium
- •Unacceptable laboratory abnormalities
- •Clinically relevant 12-lead ECG abnormalities
研究组 & 干预措施
LUZ11 PDT
Study consists of two phases, in each participant:
- Dose-finding phase with sequential periods in which single-ascending doses of LUZ11 will be titrated up to a dose that shows to be effective following photoirradiation of small spots of tumor surface.
- Final PDT session with the previously identified individual effective dose.
干预措施: LUZ11 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session
次要结局
- Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy(Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session)