NCT07258836招募中1 期
A Phase 1, Open-Label Study to Evaluate the Safety, Biodistribution, Imaging Characteristics, and Radiation Dosimetry of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Number of Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is to check how safe and well-tolerated [18F]LY4214835 injection is in healthy participants and participants with cancer. The study drug will be administered intravenously (IV) (into a vein). Participation in the study will last approximately 35 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Have a radiologically, cytologically, or histologically confirmed diagnosis of cancer
- •Are treatment-naïve to a systemic cancer therapy, OR have a documented disease progression on standard-of-care treatment (for example, failure of chemotherapy, targeted therapy or immunotherapy)
- •Have at least 1 imageable tumor that is 15 millimeter (mm) or larger in the longest diameter
- •Are overtly healthy at the Screening Visit and upon reporting to the clinic for the positron emission tomography (PET) Imaging Visit, as determined by medical evaluation including updated medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG)
排除标准
- •Are pregnant or intend to become pregnant during their participation in the study
- •Are breastfeeding or intending to breastfeed during their participation in the study
- •Have a history of risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome)
- •Are actively receiving cancer therapy or are in between cycles of treatment
- •Have a marked baseline prolongation of QT/corrected QT interval (QTc) interval (for example, repeated demonstration of a QTc interval greater than (>) 450 millisecond (ms)
研究组 & 干预措施
LY4214835 (Cohorts 1 and 2)
Experimental
LY4214835 administered intravenously (IV)
干预措施: LY4214835 (Drug)
结局指标
主要结局
Number of Incidence of Adverse Events (AEs)
时间窗: Baseline Through Day 3
Evaluation of AEs regardless of causality, will be reported in the Reported AEs module
Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose
时间窗: Baseline Through Day 3
Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
次要结局
- Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs(Baseline Through Day 3)
研究者
研究点 (6)
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