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Идёт набор NCT06046742

A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors

Фаза I С лечением 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: M1-c6v1.
Кому может быть актуально
Состояния в реестре: Solid Tumor. Базовые параметры: от 18 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
Япония
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, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients with Locally Advanced or Metastatic Solid Tumors

Обзор

A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

Подробное описание

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.

Вмешательства

  • Биопрепарат M1-c6v1
    Intravenous drip administration

Первичные конечные точки

  • Evaluate the safety and tolerability of escalating doses of intravenous M1-c6v1 in Patients with advanced malignant tumors [Срок оценки: About 2 years]
  • Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1. [Срок оценки: About 2 years]
  • Conduct a dose extension study to evaluate the safety and tolerability of intravenous administration of M1-c6v1 at maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. [Срок оценки: About 2 years]
Вторичные конечные точки (3)
  • Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1. [Срок оценки: About 2 years]
  • Assess the immunogenicity of intravenous administration of M1-c6v1. [Срок оценки: About 2 years]
  • Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators. [Срок оценки: About 2 years]

Критерии участия

Критерии включения

  • Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
  • Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
  • Males and females at least 18 years of age, inclusive, at the Screening Visit.
  • Have at least one measurable lesion.
  • An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
  • An estimated survival time of ≥ 12 weeks.

Критерии исключения

  • Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
  • Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
  • Subject has received systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
  • Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

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

Япония · 3 центра
  • National Cancer Center Hospital East — Kashiwa-shi
  • National Hospital Organization Shikoku Cancer Center — Matsuyama
  • St. Marianna University Hospital — Kawasaki-shi

Идентификаторы

NCT: NCT06046742 · VRT106-J01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗