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Идёт набор NCT06375564

Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

Фаза I С лечением Refractory Solid Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 177Lu-AB-3PRGD2 radioligand therapy.
Кому может быть актуально
Состояния в реестре: Refractory Solid Tumor. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

Обзор

This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.

Подробное описание

Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, providing an effective target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of 177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.

Вмешательства

  • Препарат 177Lu-AB-3PRGD2 radioligand therapy
    Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.

Первичные конечные точки

  • Objective response rate (ORR) [Срок оценки: At the end of Cycle 4 (each cycle is 42 days)]
Вторичные конечные точки (1)
  • Incidence of treatment-related adverse events (safety and tolerability) [Срок оценки: At the end of Cycle 4 (each cycle is 42 days)]

Критерии участия

Критерии включения

  • Ability to understand and willingness to sign a written informed consent document.
  • Age 18 and older.
  • Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
  • Progressive disease after multiple-lines treatment.
  • Eastern Cooperative Oncology Group Performance Status ≤ 3.
  • Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-RGD PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-RGD study and completion of the scan.
  • Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL.
  • Blood chemistry levels defined as AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan.

Критерии исключения

  • Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).
  • Participants with Class 3 or 4 NYHA Congestive Heart Failure.
  • Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).
  • Pregnant or lactating women.
  • Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks.
  • Has an additional active malignancy requiring therapy within the past 2 years.
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Cannot undergo PET/CT scanning because of weight limits (350 lbs).
  • INR>1.2; PTT>5 seconds above UNL.

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
  • The First Affiliated Hospital of Xiamen University — Xiamen

Идентификаторы

NCT: NCT06375564 · XMYY-2020KY067-05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗