Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors

Официальное название

A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.

Обзор

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.

Вмешательства

• Препарат ⁶⁸Ga/¹⁷⁷Lu-BRP-020063
  68Ga-BRP-020063 Injection (Diagnostic Phase): All subjects will receive a single administration of 68Ga-BRP-020063 injection. The dose of 5 mCi (185 MBq), within an acceptable range of 3-7 mCi (111-259 MBq), will be delivered via rapid consecutive intravenous bolus injection in a volume not exceeding 10 mL, followed by a saline flush. 177Lu-BRP-020063 Injection (Therapeutic Phase): Five subjects who show positive results on the 68Ga-BRP-020063 PET/CT scan will be selected to receive a single ad

Первичные конечные точки

• Adeverse Events [Срок оценки: From enrolment to 4 weeks after the first dose]

Вторичные конечные точки (3)

• PK Parameters [Срок оценки: From administration up to 168 hours post-dose]
• Biodistribution [Срок оценки: From administration up to 168 hours post-dose]
• Radiation Dosimetry [Срок оценки: from administration up to 168 hours post-dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT07439120 · IIT-2026-030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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