A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 22
- 主要终点
- Treatment related AEs and treatment related serious adverse events (SAEs).
研究概览
简要总结
The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
详细描述
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.
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
- •Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- •Have no evidence of metastatic disease confirmed by imaging
- •Be treatment naïve for IL/CM
排除标准
- •Have known contraindications or sensitivities to the study drug or laser
- •Active ocular disease
研究组 & 干预措施
Cohort 1 AU-011& Laser
Low dose of AU-011 + 1 laser application
干预措施: AU-011 (Drug)
Cohort 1 AU-011& Laser
Low dose of AU-011 + 1 laser application
干预措施: Suprachoroidal Microinjector (Device)
Cohort 1 AU-011& Laser
Low dose of AU-011 + 1 laser application
干预措施: PDT Laser (Device)
Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
干预措施: AU-011 (Drug)
Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
干预措施: Suprachoroidal Microinjector (Device)
Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
干预措施: PDT Laser (Device)
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser
Medium dose of AU-011 + 2 laser applications
干预措施: AU-011 (Drug)
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser
Medium dose of AU-011 + 2 laser applications
干预措施: Suprachoroidal Microinjector (Device)
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser
Medium dose of AU-011 + 2 laser applications
干预措施: PDT Laser (Device)
Cohort 4 AU-011 & Laser
Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
干预措施: AU-011 (Drug)
Cohort 4 AU-011 & Laser
Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
干预措施: Suprachoroidal Microinjector (Device)
Cohort 4 AU-011 & Laser
Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
干预措施: PDT Laser (Device)
Cohort 5 AU-011 & Laser
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
干预措施: AU-011 (Drug)
Cohort 5 AU-011 & Laser
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
干预措施: Suprachoroidal Microinjector (Device)
Cohort 5 AU-011 & Laser
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
干预措施: PDT Laser (Device)
Cohort 6 AU-011 & Laser
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
干预措施: AU-011 (Drug)
Cohort 6 AU-011 & Laser
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
干预措施: Suprachoroidal Microinjector (Device)
Cohort 6 AU-011 & Laser
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
干预措施: PDT Laser (Device)
结局指标
主要结局
Treatment related AEs and treatment related serious adverse events (SAEs).
时间窗: 52 weeks
Adverse Events
次要结局
- Time to reach tumor progression(52 weeks)
- Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.(52 weeks)