NCT07439120招募中1 期
A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年4月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET/CT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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, regardless of gender;
- •Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
- •Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
- •Performance status (ECOG) score of 0-1;
- •Adequate organ function:
- •Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L;
- •Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN;
- •Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
- •Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN;
- •Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females);
- •Willing to participate in this trial and sign an informed consent form.
排除标准
- •Previous treatment with Nectin-4-targeted drugs (including clinical trials);
- •Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
- •Participation in drug or device clinical studies within 4 weeks prior to the first dose;
- •Presence of severe or uncontrolled underlying diseases, including but not limited to:
- •NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;
- •Severe cardiovascular/cerebrovascular or valvular diseases;
- •Poorly controlled diabetes or hypertension;
- •Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);
- •Active infection within 4 weeks prior to the first dose;
- •Women who are planning pregnancy, currently pregnant, or breastfeeding;
- •Allergy to radioactive rays or other severe allergic history;
- •History of neurological metastasis with associated symptoms;
- •Concurrent other malignancies;
- •Undergone general anesthesia surgery within 4 weeks prior to the first dose;
- •Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.
研究者
Yan Xing
Medical Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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