An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety parameter Physical Examination
研究概览
简要总结
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed written informed consent
- •Chinese male or female≥18 years old.
- •Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
- •Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
- •Expected survival ≥ 6 months.
- •Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.
排除标准
- •Renal mass is known to be a metastasis of another primary tumor.
- •Have other malignancies that require treatment.
- •Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
- •Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 [NCICTCAE v5.0]).
- •Exposure to murine or chimeric antibodies within the last 5 years.
- •Prior use of radionuclides with an interval of less than 10 halflives.
- •Exposure to any investigational diagnostic or therapeutic agent within the first 4 weeks or 5 half-lives (whichever is longer) of the planned administration of 89Zr-TLX
- •Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m².
- •Uncontrolled psychiatric disorders.
- •Women who are pregnant or breastfeeding.
- •Known hypersensitivity to girentuximab or DFO (deferoxamine).
- •Have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease) that, in the opinion of the investigator, may interfere with the purpose of the study or subject safety or compliance.
- •Vulnerable population (e.g., being in detention).
研究组 & 干预措施
89Zr-girentuximab
A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab
干预措施: 89Zr-Girentuximab (Drug)
结局指标
主要结局
Safety parameter Physical Examination
时间窗: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Safety parameter concomitant medications
时间窗: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Safety parameter Vital Signs
时间窗: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs
Safety parameter Laboratory examinations
时间窗: 9 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Safety parameter ECG
时间窗: 9 days
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)
次要结局
- Whole blood radioactivity PK parameters(6 days)
- Radiation dosimetry(8 days)
- Tumour dosimetry(Whole body PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection)