NCT06359821已完成早期 1 期
A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting (At211) Radiopharmaceutical, in Metastatic Castration Resistant Prostate Cancer
Sichuan University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2024年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ
研究概览
简要总结
A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting (At211) Radiopharmaceutical, in metastatic castration resistant prostate cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- •Participants must be ≥18 years of age and competent to give informed consent.
- •Participants must have progressive mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate. Participants must have documented PSA and/or radiographic progression.
- •Participants must have Gallium 68 PSMA-11 (Ga 68 PSMA-11) Positron Emission Tomography (PET)/Computed Tomography (CT) prostate-specific membrane antigen (PSMA) positive lesions ≤ 30 days prior to beginning study therapy.
- •Participant has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Participants must have a life expectancy of more than 3 months.
- •Effective castration with testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration.
- •Participants must have adequate hematological and organ function.
排除标准
- •Participants with any medical condition or other circumstances that, in the opinion of the investigator, would preclude participation in this study, compromise obtaining reliable data, achieving study objectives, or completion.
- •Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma.
- •Participants with any PSMA-negative metastatic lesion these criteria were ineligible.
- •Less than 4 weeks since last myelosuppressive therapy (including prior radiotherapy or prior treatment with 223Radium, 89Strontium or 153Samarium containing compounds).
- •With active or uncontrolled infection.
- •Have used any other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment, or have used any investigational medical devices within 4 weeks prior to the start of the study treatment, and plan to receive other investigational drugs or medical devices during the course of this study.
- •Previously known to have a history of allergy, hypersensitivity, or intolerance to radioactive drugs; or known to be allergic to ethanol.
- •Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy during and for 90 days after discontinuation of study treatment.
研究组 & 干预措施
Single dose
Experimental
ZA-001, single dose
干预措施: ZA-001 (Drug)
结局指标
主要结局
The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ
时间窗: 24 hours
SPECT/CT will be scanned following administration of the ZA-001
Adverse Event
时间窗: 1 week
Number of participants with Adverse Events as a measure of safety and tolerability
次要结局
未报告次要终点
研究者
Rong Tian
MD
Sichuan University
研究点 (1)
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