A Phase I Study Evaluating the Safety and Imaging Characteristics of 18F-LY3546117 Injection in Subjects Who Are Undergoing Treatment With Immune Checkpoint Inhibitors
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cohort 1: Uptake of 18F-LY3546117 in tumor foci and other organs of the body
研究概览
简要总结
Immuno-Oncology (IO) therapies have revolutionized cancer therapy and are becoming the standard of care for many cancers. Monitoring how well IO therapies work against cancer is difficult due to the complexity of the immune system and the fact that an immune response may initially increase, rather than decrease, the size of a tumor. An early response marker would be beneficial to determine which patients should remain on a given treatment or combination of treatments, and which patients should seek other treatment options. 18F-LY3546117 is a radiolabeled tracer that binds to a specific protein (Granzyme B) that is found in the human immune system and is thought to trigger programmed cell death. It is thought that imaging Granzyme B activity in tumors and elsewhere in the body using a Positron Emission Tomography (PET) scan will allow doctors to monitor the progress of IO therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 未提供
排除标准
- •Subjects who plan to receive chemotherapy or radiation therapy during study participation
- •Prior history of failed immune checkpoint inhibitor therapy
- •Subjects who require steroid or other immunosuppressive medications within 2 weeks of the PET scan.
- •Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using effective methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening and agree to avoid becoming pregnant for 24 hours following study drug administration.
- •Females and males must agree to refrain from sexual activity or to use effective contraceptive methods for 24 hours following study drug administration and during study participation
研究组 & 干预措施
18F-LY3546117 Scan Cohort 1
18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy
干预措施: PET Scan (Procedure)
18F-LY3546117 Scan Cohort 1
18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy
干预措施: 18F-LY3546117 Injection (Drug)
18F-LY3546117 Scan Cohort 2
18F-LY3546117 PET scan at time of immune checkpoint therapy response
干预措施: 18F-LY3546117 Injection (Drug)
18F-LY3546117 Scan Cohort 2
18F-LY3546117 PET scan at time of immune checkpoint therapy response
干预措施: PET Scan (Procedure)
结局指标
主要结局
Cohort 1: Uptake of 18F-LY3546117 in tumor foci and other organs of the body
时间窗: Day 14 up to Day 42 of immune checkpoint inhibitor therapy
Visual uptake in the tumor as assessed by sponsor expert reader (Yes/No)
Cohort 2: Uptake of 18F-LY3546117 in tumor foci and other organs of the body
时间窗: At immune checkpoint inhibitor treatment response (Day 42 up to 6 months post-treatment)
Visual uptake in the tumor as assessed by sponsor expert reader (Yes/No)
次要结局
未报告次要终点