A First-in-human, Non-randomised, Single-arm Pilot and Feasibility Study of [68Ga]Ga-THP-PDL1-3 PET/CT in Patients With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety and Feasibility
研究概览
简要总结
To utilize the [68Ga]Ga-THP-PDL1-3 molecular probe to non-invasively detect PD-L1 expression in primary and metastatic lesions of patients with solid tumors. Furthermore, to assess the heterogeneity of PD-L1 expression within the same lesion and across different lesions, and to observe changes in PD-L1 expression during the course of treatment. This approach aims to facilitate patient screening, therapeutic monitoring, and early warning of drug resistance and/or recurrence or metastasis in the treatment of solid tumors with high PD-L1 expression, ultimately enabling personalized targeted therapy in oncology.
详细描述
Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years, ECOG score 0 or 1;
- •Patients with solid tumors;
- •Presence of measurable lesions on imaging examinations;
- •Expected survival ≥12 weeks.
排除标准
- •Severe hepatic or renal dysfunction;
- •Women who are planning pregnancy, pregnant, or breastfeeding;
- •Unable to remain in supine position for 30 minutes;
- •Refusal to participate in this clinical study;
- •Diagnosis of claustrophobia or other psychiatric disorders;
- •Other conditions deemed by the investigator as inappropriate for participation in the trial.
研究组 & 干预措施
[68Ga]Ga-THP-PDL1-3
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]Ga-THP-PDL1-3 PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of [68Ga]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection.
干预措施: [68Ga]Ga-THP-PDL1-3 (Drug)
[68Ga]Ga-THP-PDL1-3
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]Ga-THP-PDL1-3 PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of [68Ga]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Safety and Feasibility
时间窗: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.
1. Adverse Event Number of participants with tracer-related adverse events. 2. Feasibility of PET/CT Imaging Number of participants in whom evaluable PET/CT images were successfully acquired at prespecified time points, as independently assessed by a senior nuclear medicine physician. Images were considered evaluable if they met diagnostic quality criteria. 3. Quality Control Standards for the Radiotracer Radiochemical purity ≥95% (determined by iTLC); Sterility (tested by the direct inoculation method according to pharmacopoeial standards); Bacterial endotoxins ≤15 EU/mL (as determined by photometry). 4. Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema. Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder. Safety and feasibility were evaluated by no adverse events after comprehensive indicators.
Standardized uptake value（SUV）
时间窗: 2 years
The uptake of the tracer （68Ga-THP-PD-L1-3) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.
次要结局
- Standardized Uptake Value (SUV)(Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.)
研究者
Hua Zhu
Principal Investigator
Peking University Cancer Hospital & Institute