A Phase I Study Assessing the Safety, Pharmacokinetics, Radioactivity Distribution，Radiation Safety and Preliminary Diagnostic Performance of 68Ga-NYM096 Injection in Participants With Indeterminate Renal Masses
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
研究概览
简要总结
68Ga-NYM096 is a carbonic anhydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for the detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study is to evaluate the safety, pharmacokinetics, radioactivity distribution, radiation safety and preliminary diagnostic performance in participants with indeterminate renal masses (IRM)
详细描述
This will be a prospective, open-label, single-center phase I study. Histological confirmation will serve as standard of truth, to assess sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), as well as accuracy of 68Ga-NYM096 PET/CT Imaging.
A total of 20~40 participants with IRM scheduled for surgical resection will be enrolled and assigned to two dose groups. Each participant will receive a single injection of the assigned dose; dose escalation within the same participant is not permitted. The study includes screening period, dosing/imaging period, safety follow-up visit, and surgery follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- •Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM
- •Age ≥18 years at the time of signing the informed consent form;
- •ECOG score 0-2;
- •Life expectancy ≥6 months;
- •Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing;
- •Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures
排除标准
- •A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
- •Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer.
- •Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.
- •Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT.
- •Received other investigational drugs before 68Ga-NYM096 PET/CT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer.
- •Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance.
- •Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus [HCV] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies).
- •Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination.
- •Other situations where the investigator considers the participant unsuitable for this study
研究组 & 干预措施
⁶⁸Ga-NYM096 Injection
干预措施: 68Ga-NYM096 injection (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
时间窗: 4 days
Incidence of abnormal laboratory test results, abnormal vital signs and ECG
次要结局
未报告次要终点