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Идёт набор NCT07070349

A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors

Фаза I / Фаза II С лечением Patients With Solid Tumors

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: HRS-6213.
Кому может быть актуально
Состояния в реестре: Patients With Solid Tumors. Базовые параметры: 18 лет — 75 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

A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors

Обзор

The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.

Вмешательства

  • Препарат HRS-6213
    HRS-6213 IV administered as imaging agent for PET scan.

Первичные конечные точки

  • Phase 1: Incidence of adverse events (AEs) of HRS-6213 [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 1: Radiation dosimetry [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 2: With reference to the Standard of Truth (SOT), evaluate the diagnostic efficacy indicators of HRS-6213 PET at the lesion level [Срок оценки: rom first dose of study drug to end of treatment (up to approximately 60 days)]
Вторичные конечные точки (9)
  • Phase 1: Cmax [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 1: Biological half-life (t½) [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 1: Tmax [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 1: urinary cumulative excretion rate [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 1: Lesion uptake curve [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 1: Image quality score [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 2: The proportion of subjects with changes in disease staging and treatment decisions before and after HRS-6213 PET imaging. [Срок оценки: From first dose of study drug to end of treatment (up to approximately 60 days)]
  • Phase 2: Intra-observer consistency of the diagnosticians' results [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]
  • Phase 2:Incidence of adverse events (AEs) of HRS-6213 [Срок оценки: From first dose of study drug to end of treatment (up to approximately 7 days)]

Критерии участия

Критерии включения

  • Voluntarily sign the informed consent form; willing and able to follow the study protocol.
  • For healthy subjects：BMI 18\~28kg/m2
  • For patients：
  • ECOG 0-1
  • Patients with pathologically confirmed tumour
  • proposed surgical resection/exploration (including primary or recurrent metastatic tumour
  • sufficient organs function.

Критерии исключения

  • Known severe allergic reactions, hypersensitivity or contraindications to the test drug or any component of its preparation, such as alcohol allergy or other allergic history that the investigator deems may increase the risk of the trial.
  • Received the following treatments before administration:
  • Received radionuclide diagnostic or therapeutic drugs before administration, and less than 10 physical half-lives have elapsed since the last administration.
  • Used any intravenous iodinated contrast agent within 24 hours before administration, or used any high-density oral contrast agent within 5 days before administration (oral water-based contrast agent is acceptable).
  • Concurrent infectious diseases
  • Severe urinary incontinence, hydronephrosis, severe micturition dysfunction.
  • Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration.
  • Unexplained fever > 38.5℃ lasting for more than 1 hour during screening or before administration.
  • Concurrent severe or poorly controlled cardiac diseases or symptoms, including but not limited to: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 6 months before administration, QTcF > 450 msec in males or QTcF > 470 msec in females.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Китай · 1 центр
  • Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07070349 · HRS-6213-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗