Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis.
研究概览
简要总结
The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.
详细描述
A phase I study with an initial concentration/volume escalating part followed by an expanded cohort at the recommended dose (RD). This is an open label, multicentre study assessing the safety, tolerance, PK and efficacy of LTX-315 injected directly into transdermally accessible tumours on days 1 and 8.
Additional weekly injections may be made, for up to a total of 6 injections.
Subjects may be included in the study if they meet all of the following criteria:
- Histologically confirmed malignant tumour
- Transdermally accessible lesion (in or close to the skin)
- Age ≥ 18 years
- ECOG Performance status (PS): 0 - 2
- Life expectancy: At least 3 months
The primary objectives of the study are to evaluate the safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study and to determine the recommended dose of LTX-315.
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
- •Histologically confirmed malignant tumour. Transdermally accessible lesion (in or close to the skin) of 1 - 5 cm in diameter.
- •ECOG Performance status (PS): 0 - 2
- •Life expectancy: At least 3 months
排除标准
- 未提供
结局指标
主要结局
Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis.
时间窗: 12 weeks
次要结局
- Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.(12 weeks)
- Core biopsy staining for lymphocyte infiltratio(12 weeks)
- Tumour volume measurment(12 weeks)