A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vical
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
研究概览
简要总结
To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.
详细描述
Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s).
Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks.
Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.
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
- •Key criteria include:
- •Confirmed recurrent metastatic melanoma
- •Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
- •Able to carry out normal daily activities and light work without assistance
- •Not currently receiving chemotherapy or immunotherapy
- •Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
- •Able and willing to give informed consent.
排除标准
- •Key criteria include:
- •History of brain tumors (resected or stereotactically treated is allowed)
- •History of liver tumors
- •Subjects whose melanoma can be cured by surgery
- •Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.
研究组 & 干预措施
A
IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).
干预措施: VCL-IM01 (encoding IL-2) with Electroporation (Genetic)
结局指标
主要结局
Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
时间窗: After all subjects have been enrolled
次要结局
- Overall response rate, duration of response, treated tumor response rate, assessment of injected tumor(s) for induration, inflammation, and erythema, and serum levels of IL-2.(After all subjects have been enrolled)