A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- the safety and tolerability of TRDC002 in participants
研究概览
简要总结
TRDC002 uses a radioactive form (64Cu) to trace the PSMA positive prostate cancer. The purpose of this study is to investigate TRDC002 as a PSMA PET tracer to localize PSMA positive lesions in adult patients with recurrent or metastatic prostate cancer. We plan to assess the PSMA PET/CT image quality following administration of two dose levels of TRDC002 to determine an acceptable dose and optimal acquisition time for obtaining diagnostic quality PET/CT images. The safety and tolerability, PK, biodistribution, dosimetry of TRDC002 will also be evaluated in this study.
详细描述
This is a prospective, randomized, open-label, phase I study to evaluate safety and tolerability, PK, biodistribution, dosimetry and preliminary efficacy of TRDC002 for PET/CT imaging in participants with PSMA-positive recurrent or metastatic prostate cancer compared with CRS.
At screening, the participants will be assessed for eligibility and will undergo PSMA PET to screen PSMA positive patients.
Eligible participants with recurrent or metastatic prostate cancer will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002 intravenously. Whole-body PET/CT images will be acquired at 1hr, 4hr, 7hr, and 24hr post-injection to observe radiation absorbed dose and pharmacokinetics. Independent review committee (IRC) will evaluate the quality of PET images to determine an acceptable dose and optimal acquisition time for PET scan, and preliminary efficacy compared with Composite Reference Standard (CRS) based on CT/MRI with contrast and bone scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Three independent readers will be blinded to all participants information and doses administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants with recurrence or metastasis of prostate cancer.
- •Participants with PSMA-positive lesions.
- •Participants must have adequate bone marrow and organ function.
- •Participants with an ECOG performance status of 0 or 1.
排除标准
- •Any immunotherapy or biological therapy (including antibodies) targeting PSMA within 60 days prior to the day of randomization.
- •A superscan is observed in the baseline bone scan.
- •Concurrent serious (as determined by the Investigator) medical conditions
- •Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.
研究组 & 干预措施
4 mCi of TRDC002
Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
干预措施: Intravenous (IV) single dose (Drug)
6 mCi of TRDC002
Patients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
干预措施: Intravenous (IV) single dose (Drug)
结局指标
主要结局
the safety and tolerability of TRDC002 in participants
时间窗: 3 days
Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan.(At 1 hour, 4 hours, 7 hours, and 24 hours post injection.)
- The biodistribution of TRDC002.(At 1 hour, 4 hours, 7 hours, and 24 hours post injection.)
- The dosimetry of TRDC002.(At 1 hour, 4 hours, 7 hours, and 24 hours post injection.)
- Pharmacokinetics of TRDC002.(Within 1 minute, 10 minutes, and 30 minutes, and at 60 minutes, 2 hours, 6 hours and 24 hours for blood PK, and 0-60 minutes, 1-2 hours, 2-6 hours, and 6-24 hours for urine PK.)