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Идёт набор NCT06979674

Study of ESG406 in Adults With Solid Tumors

Фаза I С лечением Locally Advanced/Metastatic 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: ESG406.
Кому может быть актуально
Состояния в реестре: Locally Advanced/Metastatic Solid Tumors. Базовые параметры: 18 лет — 80 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
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Официальное название

An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced/Metastatic Solid Tumors

Обзор

This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.

Вмешательства

  • Препарат ESG406
    Administered via intravenous (IV) infusion.

Первичные конечные точки

  • Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events [Срок оценки: First dose date up to last dose plus 30 days]
Вторичные конечные точки (6)
  • Objective Response Rate [Срок оценки: Up to approximately 36 months.]
  • Progression Free Survival [Срок оценки: Up to approximately 36 months.]
  • Cmax [Срок оценки: Up to approximately 36 months.]
  • AUC0-inf [Срок оценки: Up to approximately 36 months.]
  • T1/2 [Срок оценки: Up to approximately 36 months.]
  • Anti-drug Antibodies [Срок оценки: Up to approximately 36 months.]

Критерии участия

Критерии включения

  • Males and females aged 18 to 80 years.
  • Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
  • At least one measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Adequate organ and bone marrow function.
  • Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause.

Критерии исключения

  • Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.
  • Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
  • Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
  • Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration.
  • A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug.
  • History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening.
  • Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
  • Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.
  • Patients with uncontrollable systemic diseases.
  • Subjects with clinically significant cardiovascular disease.
  • Human Immunodeficiency Virus (HIV) infection.
  • Active hepatitis B or hepatitis C.
  • Have an allergic constitution, or to be allergic to any investigational drug or excipient ingredient.
  • Pregnant or lactating women.

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 · 3 центра
  • Chongqing University Cancer Hospital — Чунцин
  • The First Affiliated Hospital of Xi 'An Jiaotong University — Xi’an
  • The Second Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06979674 · ESG406-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗