A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 13
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
研究概览
简要总结
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
详细描述
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.
Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.
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
- 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
- •Diagnosis of choroidal melanoma
排除标准
- •Have known contraindications or sensitivities to the study drug
研究组 & 干预措施
Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
干预措施: Laser Activation (Device)
Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
干预措施: Light-activated AU-011 (Drug)
Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
干预措施: Laser Activation (Device)
Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
干预措施: Light-activated AU-011 (Drug)
Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
干预措施: Laser Activation (Device)
Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
干预措施: Light-activated AU-011 (Drug)
2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
干预措施: Light-activated AU-011 (Drug)
2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
干预措施: Laser Activation (Device)
3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
干预措施: Light-activated AU-011 (Drug)
3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
干预措施: Laser Activation (Device)
Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
干预措施: Light-activated AU-011 (Drug)
Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
干预措施: Laser Activation (Device)
3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
干预措施: Light-activated AU-011 (Drug)
3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
干预措施: Laser Activation (Device)
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
干预措施: Light-activated AU-011 (Drug)
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
干预措施: Laser Activation (Device)
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
干预措施: Light-activated AU-011 (Drug)
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
干预措施: Laser Activation (Device)
Observation until Documented Growth of Tumor
Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
干预措施: Light-activated AU-011 (Drug)
Observation until Documented Growth of Tumor
Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
干预措施: Laser Activation (Device)
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
干预措施: Light-activated AU-011 (Drug)
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
干预措施: Laser Activation (Device)
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
干预措施: Light-activated AU-011 (Drug)
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
干预措施: Laser Activation (Device)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
时间窗: Informed consent through 1-2 years
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
次要结局
- Immunogenicity (Anti-AU-011 Antibody Analysis)(Screening to various time points through 24 months)
- Tumor Size (Thickness) Measured by Ultrasonography [Efficacy](Change from baseline following treatment and at each subsequent visit through Week 52)
- Tumor Size (Diameter) Measured by Fundus Photography [Efficacy](Change from baseline following treatment and at each subsequent visit through Week 52)
- Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye(Change from baseline following treatment and at each subsequent visit through Week 52)