NCT05725070已完成早期 1 期
Phase 0/1 Theragnostic Study in Patients With Metastatic Castration Resistant Prostate Cancer in Need of Salvage Therapy, Selected by 18F-PSMA-PET Imaging and Treated by Alpha-therapeutic Radioligand 212Pb-NG001
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
- ARTBIO Inc.
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
研究概览
简要总结
The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.
详细描述
This is a single site, open label, non-randomized, non-controlled intervention study with an initial microdosing run-in part (phase 0), followed by a conventional dose-escalation phase 1 part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •ECOG performance status of 0 to 2
- •Life expectancy >6 months
- •Histological, pathological, and/or cytological confirmation of prostate cancer
- •Metastatic castration resistant prostate cancer
- •Failure of conventional treatment or such treatment not available/accepted by patient
- •PSMA avid mCRPC lesions confirmed by PSMA PET/CT
- •Adequate hematopoietic, kidney and liver function
排除标准
- •Concurrent or other cancer diagnosis last two years, except for carcinoma in situ
- •Concomitant diseases not compatible for radioactive therapy
- •Previous PSMA-targeted radioligand therapy
- •Concurrent serious (as determined by the Principal Investigator) medical conditions
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Drug
Experimental
212Pb-NG001
干预措施: 212Pb-NG001 (Drug)
结局指标
主要结局
Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
时间窗: Up to 28 days
To qualitatively determine whether 212Pb-NG001 can be used to produce images of sufficient clarity and sensitivity by SPECT/CT to confirm 212Pb-NG001 uptake and biodistribution.
次要结局
- Body clearance(Up to 2 days)
- Safety and tolerability(Up to 28 days)
- Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP(Up to 28 days)
研究者
研究点 (1)
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