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Идёт набор NCT07348653

A Study of MG2512 Injection in Participants With Advanced Solid Tumors

Фаза I С лечением Advanced 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: MG2512 Injection.
Кому может быть актуально
Состояния в реестре: Advanced Solid Tumor. 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 Study of Safety, Tolerability, Pharmacokinetics and Efficacy of MG2512 Injection in Participants With Advanced Solid Tumors

Обзор

This is an open-label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of MG2512 injection in participants with advanced solid tumors.

Вмешательства

  • Препарат MG2512 Injection
    MG2512 injection.

Первичные конечные точки

  • Dose limiting toxicity (DLT) [Срок оценки: 3 weeks.]
  • Maximum tolerated dose (MTD) [Срок оценки: 3 weeks.]
  • Recommended Phase 2 Dose (RP2D) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Adverse events (AEs) [Срок оценки: From screening period up to study completion, an average of 1 year.]
Вторичные конечные точки (9)
  • Blood concentration of MG2512 after single and continuous administration [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Time to reach maximum plasma concentration (Tmax) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Maximum plasma Concentration (Cmax) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Area under the curve from zero to time t (AUC0-t) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Drug Resistant Antibody (ADA) to MG2512 [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Objective response rate (ORR) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Disease control rate (DCR) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Progression-free survival (PFS) [Срок оценки: From screening period up to study completion, an average of 1 year.]
  • Overall survival (OS) [Срок оценки: From screening period up to study completion, an average of 1 year.]

Критерии участия

Критерии включения

  • Voluntary participation and written informed consent.
  • 18-75 years old, no gender limitation.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1.
  • With a life expectancy ≥ 3 months.
  • Patients with recurrent or metastatic solid tumors that have been histologically or cytologically confirmed to be incurable through surgery or radical radiotherapy and chemotherapy, who have experienced disease progression after standard treatment, or have no standard treatment plan, or are not suitable for standard treatment.
  • Be able to provide fresh or archived tumour tissue.
  • At least one measurable lesion according to RECIST v1.1.
  • Adequate bone marrow reserve and organ function.
  • Contraception is required during the trial.

Критерии исключения

  • Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
  • History of other malignant tumors within 5 years before the first use of the study drug.
  • Uncontrollable tumor-related pain or symptomatic hypercalcemia.
  • Having severe cardiovascular and cerebrovascular diseases.
  • Presence of bleeding symptoms with significant clinical significance within 3 months before the first use of the study drug.
  • Uncontrollable effusion within 2 weeks before the first use of the study drug.
  • Subjects with history of interstitial pneumonia or lung diseases that severely affect lung function.
  • Having a severe infection within 4 weeks before the start of study treatment.
  • History of immunodeficiency, including positive HIV test results; presence of active hepatitis B.
  • Subjects with active pulmonary tuberculosis infection within 1 year before enrollment.
  • Adverse reactions from previous antitumor treatment that have not recovered to CTCAE ≤ Grade 1.
  • Failure to meet the following requirements for previous treatment washout: receipt of anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, immunotherapy, or other non-marketed investigational drug treatments within 4 weeks before the first use of the study drug.
  • Receipt of chest radiotherapy with a dose > 30 Gy within 24 weeks before the first use of the study drug.
  • Subjects with previous or planned allogeneic bone marrow transplantation or solid organ transplantation.
  • Subjects with known allergy to any component or excipient of the MG2512 product.
  • Subjects with other factors that may affect the study results or lead to forced premature termination of the study, as judged by the investigator.

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 · 2 центра
  • Peking Union Medical College Hospital — Пекин
  • Sichuan Cancer Hospital — Чэнду

Идентификаторы

NCT: NCT07348653 · MG2512-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗