A Dosimetry Study and Dose-escalation and of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Hematologic adverse events collection
研究概览
简要总结
This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).
详细描述
[177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •progressive metastatic castration-resistant prostate cancer
- •tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT
排除标准
- •a serum creatinine level of more than 150 μmol per liter
- •a hemoglobin level of less than 10.0 g/dl
- •a white-cell count of less than 4.0× 109/L
- •a platelet count of less than 100 × 109/L
- •a total bilirubin level of more than 3 times the upper limit of the normal range
- •a serum albumin level of more than 3.0 g per deciliter
- •cardiac insufficiency
研究组 & 干预措施
LNC1011 Dose escalation
Patients received a single dose of 1.85 GBq (50 mCi) of 177Lu-LNC1011 via intravenous injection, followed by monitoring at 3, 24, 48, 72, and 168 hours post-injection. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.
干预措施: 177Lu-LNC1011 (Drug)
结局指标
主要结局
Hematologic adverse events collection
时间窗: through study completion, an average of 6 months
Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Total white cell count less than 2.5 × 10\^9/L,Platelet count less than 75 × 10\^9/L
Dosimetry of normal organs and tumors
时间窗: through study completion, an average of 4 weeks
The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-LNC1011. The dose delivered to normal organs and tumors will be recorded.
Liver and renal toxic events collection
时间窗: through study completion, an average of 6 months
Liver and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Progressive deterioration of organ function (GFR \<30 mL/min or creatinine \> 2-fold upper limit of normal (ULN); liver enzymes \> 5-fold ULN).
次要结局
- PSA Response(through study completion, an average of 6 months)
- Pharmacokinetics and dosimetry(Whole-body (WB) scans were performed at 2, 4, 24, 48, 72, 120, and 168 hours following intravenous administration of [177Lu]Lu-LNC1011)