Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06: A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
研究概览
简要总结
This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of [177Lu]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.
详细描述
This study represents a comprehensive "bench-to-bedside" translational investigation, providing the first systematic report on the safety profile of [177Lu]Lu-TEFAPI-06-a novel albumin-binding fibroblast activation protein inhibitor (FAPI) radiopharmaceutical-and its successful transition into a FIH. The investigators preliminarily evaluated its safety, dosimetry, and therapeutic response in patients with ibroblast activation protein (FAP)-overexpressing metastatic solid tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically confirmed advanced metastatic solid tumors refractory or intolerant to standard therapies
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •At least one FAP-avid lesion confirmed by baseline [18F]-FAPI PET/CT
- •Adequate organ and bone marrow function prior to the first dose
排除标准
- •Chemotherapy, radiotherapy, or targeted therapy within 4 weeks
- •Severe hepatic or renal dysfunction
- •Uncontrolled active infection or severe comorbidities
研究组 & 干预措施
Patients with advanced metastatic solid tumors
干预措施: radionuclide therapy with [177Lu]Lu--TEFAPI-06 (Drug)
结局指标
主要结局
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
时间窗: From Baseline up to 30 days after the last dose of study intervention (approximately 4 weeks)
Safety and tolerability will be assessed by recording the frequency, duration, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). The assessment includes clinically significant changes in vital signs (blood pressure, heart rate, respiratory rate, temperature), physical examination findings, 12-lead Electrocardiogram (ECG) parameters, and clinical laboratory tests (including Complete Blood Count \[CBC\], Urinalysis, Liver Function Tests \[LFTs\], and Renal Function Tests). Severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
次要结局
- Change from Baseline in [18F]-FAPI PET/CT Parameters in Target Lesions(Baseline (Day 0) and 1 month post-treatment.)
- Change from Baseline in Tumor-Specific Serum Marker Levels(Baseline (Day 0) and 1 month post-treatment.)
研究者
Jiangyan Liu
Director of the Nuclear Medicine Department of the Second Hospital of Lanzhou University
Lanzhou University Second Hospital