Меню
Набор скоро начнётся NCT06933524

Evaluation of Safety and Tolerability of ATB-320 in Participants With Progressive or Metastatic Solid Tumors

Фаза I С лечением 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: ATB-320.
Кому может быть актуально
Состояния в реестре: Solid Tumors. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of ATB-320 in Patients With Progressive or Metastatic Solid Tumors

Обзор

The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors

Подробное описание

1. Primary objective: to evaluate the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D), and dose limiting toxicities (DLTs) of ATB-320 in patients with progressive or metastatic solid tumors. 2. Secondary objective: to evaluate safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors. 3. Exploratory objective: to evaluate pharmacokinetics, pharmacodynamics, and efficacy of ATB-320 in patients with progressive or metastatic solid tumors.

Вмешательства

  • Препарат ATB-320
    IV infusion

Первичные конечные точки

  • Dose Limiting Toxicity (DLT) [Срок оценки: First dose to Cycle 1 Day 28 (each cycle is 28 days)]
  • Maximum Tolerated Dose (MTD) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
Вторичные конечные точки (1)
  • Safety [Срок оценки: At the end of each cycle (each cycle is 28 days) and up to 14 days from the last dose of ATB-320]

Критерии участия

Критерии включения

  • Adult (18 years or older) at the time of screening
  • Histologically confirmed solid tumor
  • Participants must have failed standard therapy or cannot tolerate standard therapy.
  • Participants must be able to provide tissue samples, either stored at the institution or obtained from a biopsy performed prior to administration of the investigational product, and have tumor that can be safely biopsied throughout the study.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Life expectancy of ≥ 12 weeks

Критерии исключения

  • Has received chemotherapy within 21 days prior to the first planned dose of the investigational product, or if less than 5 times the half-life of the chemotherapeutic has passed (whichever is shorter)
  • Has received immunotherapy within 2 weeks of the first planned dose of investigational product
  • Major surgery within 4 weeks prior to the first planned dose of the investigational product
  • Previous malignant tumors, other than the target indication to be investigated in this study, within 3 years prior to screening (participants with locally malignant tumors such as basal cell carcinoma/squamous cell carcinoma of the skin, carcinoma in situ (cervix, breast), thyroid papillary carcinoma that have undergone potentially curative therapy are eligible to participate in the study.
  • Current enrollment in any other clinical trial or has received another investigational product or medical device treatment within 28 days of first planned dose (participants who are undergoing safety follow-up phase of a clinical trial may participate if more than 28 days have passed since the last dose of the previous investigational product)
  • Has received prior radiotherapy within 2 weeks of the first planned dose. Participants who have received palliative radiotherapy for non-central nervous system (CNS) disease within 2 weeks of first planned dose are allowed to participate after 1-week washout (participants must have recovered from any radiation-related toxicities, not require corticosteroid treatment, and without radiation pneumonitis)
  • History of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06933524 · ATB-320-001A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗