NCT06139575招募中1 期
Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
Bivision Pharmaceuticals, Inc.13 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- Dose Limiting Toxicity (DLT) (Phase 1)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
- •Male, age ≥18 years.
- •ECOG score 0 -
- •Must have a life expectancy >6 months.
- •Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).
- •Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7nmol/L).
排除标准
- •Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.
- •Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
- •Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation <6 months prior to date of first administration of investigational drug.
- •Previous PSMA-targeted radioligand therapy.
- •Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
- •Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug.
- •Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.
- •History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
研究组 & 干预措施
Lutetium Lu 177 JH020002 Injection
Experimental
干预措施: Lutetium Lu 177 JH020002 Injection (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT) (Phase 1)
时间窗: Up to 2 years follow up
Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
Maximum Tolerated Dose (MTD) (Phase 1)
时间窗: Up to 2 years follow up
The maximum tolerated dose is among the explored dose levels.
Recommended Phase 2 Dose (RP2D) (Phase 1)
时间窗: Up to 2 years follow up
To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.
PSA response rate
时间窗: Up to 3 years follow up
PSA response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of \>= 50% from baseline that is confirmed by a second consecutive PSA measurement \>= 4 weeks later. Determination of response status will be based on PCWG3 recommendations.
次要结局
- Maximum plasma concentration (Cmax)(Up to 2 years follow up)
- Time to maximum plasma concentration (Tmax)(Up to 2 years follow up)
- Terminal elimination half-life (t1/2)(Up to 2 years follow up)
- Total systemic clearance (CL)(Up to 2 years follow up)
- Radiation Dosimetry(Up to 2 years follow up)
- Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)(Up to 2 years follow up)
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)(Up to 2 years follow up)
- Volume of distribution (Vz) during the terminal phase following intravenous elimination(Up to 2 years follow up)
- Radiographic Progression-free Survival (rPFS)(Up to 3 years follow up)
- Disease control Rate (DCR)(Up to 3 years follow up)
- Duration of Response (DoR)(Up to 3 years follow up)
- Time to First Subsequent Therapy (TFST)(Up to 3 years follow up)
- Overall Survival (OS)(Up to 3 years follow up)
- Time to Symptomatic Skeletal Event (TTSSE)(Up to 3 years follow up)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)(Up to 3 years follow up)
- Objective Response Rate (ORR) (Phase 2)(Up to 2 years follow up)
研究者
研究点 (13)
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