A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 14
- 主要终点
- Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
研究概览
简要总结
The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
详细描述
This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
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
- •Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
- •Have at least one Metastases to the Choroid in the study eye
排除标准
- •Active ocular infection or disease.
- •Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.
- •Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment
研究组 & 干预措施
40 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 40 micrograms
干预措施: AU-011 (Drug)
40 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 40 micrograms
干预措施: SCS Microinjector (Device)
40 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 40 micrograms
干预措施: Laser (Device)
80 micrograms of bel-sar
1 Cycle AU-011 with a dose of 80 micrograms
干预措施: AU-011 (Drug)
80 micrograms of bel-sar
1 Cycle AU-011 with a dose of 80 micrograms
干预措施: SCS Microinjector (Device)
80 micrograms of bel-sar
1 Cycle AU-011 with a dose of 80 micrograms
干预措施: Laser (Device)
140 micrograms of bel-sar
1 Cycle AU-011 with a dose of 140 micrograms
干预措施: AU-011 (Drug)
140 micrograms of bel-sar
1 Cycle AU-011 with a dose of 140 micrograms
干预措施: SCS Microinjector (Device)
140 micrograms of bel-sar
1 Cycle AU-011 with a dose of 140 micrograms
干预措施: Laser (Device)
200 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 200 micrograms
干预措施: AU-011 (Drug)
200 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 200 micrograms
干预措施: SCS Microinjector (Device)
200 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 200 micrograms
干预措施: Laser (Device)
200 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 200 micrograms
干预措施: AU-011 (Drug)
200 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 200 micrograms
干预措施: SCS Microinjector (Device)
200 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 200 micrograms
干预措施: Laser (Device)
40 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 40 micrograms
干预措施: AU-011 (Drug)
40 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 40 micrograms
干预措施: SCS Microinjector (Device)
40 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 40 micrograms
干预措施: Laser (Device)
Observational
Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment.
结局指标
主要结局
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
时间窗: 4 weeks after completion of treatment
B-Scan Ultrasonography
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.
时间窗: 4 weeks after completion of treatment
Fundus photos
次要结局
未报告次要终点