[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002
研究概览
简要总结
The purpose of this study is to evaluate the safety of [68Ga]Ga-NOTA-SNA002 and investigate the uptake of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of [68Ga]Ga-NOTA-SNA002 (1.0-5.0mCi) in Day1 and will undergo PET/CT scanning to determine uptake of [68Ga]Ga-NOTA-SNA002 in tumor lesions and reference tissues.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years (including boundary values);
- •Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
- •Performance status (ECOG) score 0-2 points (see Appendix 1 for details);
- •Basal heart rate 60-100 beats/min (including boundary values);
- •Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);
- •Patients with confirmed solid tumors;
- •Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
- •Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FluroDeoxyGlucose(FDG) PET/CT results are acceptable);
- •Patients obtained with immunohistochemical PD-L1 expression results within the previous month.
排除标准
- •Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment;
- •Those who have extremely poor nutritional status and cannot tolerate the trial;
- •Known or suspected evidence of active autoimmune disease;
- •Patients taking high doses of hormones, such as more than 20mg of hydrocortisone or 5mg of prednisone in the morning and more than 10mg of hydrocortisone or 2.5mg of prednisone at night；
- •Those with known severe allergy to SNA002, similar drugs or excipients；
- •Patients with brain metastases；
- •Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies；
- •Women who are pregnant or breastfeeding.
- •Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
结局指标
主要结局
Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002
时间窗: 1 month
By analyzing anti-SNA002 anti-drug antibody positive rate.
Incidence of adverse events
时间窗: Time of infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) through Visit（Day 6）
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of \[68Ga\]Ga-NOTA-SNA002.
Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET
时间窗: 1 month
Description of biodistribution patterns of \[68Ga\]Ga-NOTA-SNA002 on PET.
Changes of vital signs in participants compared with baseline results.
时间窗: Baseline and 6 hours after infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) and 2 hours after tumor biopsy(Day 2)
Number of participants in CTCAE 5.0 Stage 1 or higher with vital signs after administration
Changes in laboratory values compared with baseline results.
时间窗: Baseline and Visit（Day 6）
Number of participants in CTCAE 5.0 Stage 1 or higher with laboratory examination(e.g. WBC, RBC, HB and other laboratory tests) after administration.
次要结局
- Standard Uptake Value(max) in tumors(12 months)
- Standard Uptake Value(peak) in tumors(12 months)
- Standard Uptake Value(mean) in tumors(12 months)
- Correlation of [68Ga]Ga-NOTA-SNA002 uptake in biopsied tumors with PD-L1 measurement by immunohistochemistry (IHC)(12 months)