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Набор скоро начнётся NCT07726212

A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002

Фаза I С лечением Advanced Esophageal Cancer Advanced Lung Cancer

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: MC002（ADC）.
Кому может быть актуально
Состояния в реестре: Advanced Esophageal Cancer, Advanced Lung Cancer. 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 →

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Официальное название

A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors

Обзор

The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are: Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002 . Participants will: Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms

Вмешательства

  • Препарат MC002（ADC）
    MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days. MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle

Первичные конечные точки

  • To assess the Number of patients with Adverse Events (AE) [Срок оценки: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up]
  • Determination of MTD or RP2D [Срок оценки: From enrollment until 28 days after last study drug]
Вторичные конечные точки (6)
  • Maximum concentration (Cmax) [Срок оценки: From enrollment until 28 days after last study drug]
  • ADA [Срок оценки: From enrollment until 28 after last study drug]
  • The time taken to reach the maximum concentration (Tmax) [Срок оценки: From enrollment until 28 days after last study drug]
  • Area Under Curve (AUC) [Срок оценки: From enrollment until 28 days after last study drug]
  • Half life (T1/2) [Срок оценки: From enrollment until 28 days after last study drug]
  • Trough concentration (Cmin) [Срок оценки: From enrollment until 28 days after last study drug]

Критерии участия

Критерии включения

  • 18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
  • Life expectancy of 3 month or greater
  • participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
  • At least one measurable lesion as assessed by RECIST 1.1
  • Adequate organ functions.
  • ECOG Performance Status (PS) of 0-1

Exclusion Criteria：

  • Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
  • Known hypersensitivity to either the drug substances or inactive ingredient
  • Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
  • Participants with QTc >470 msec.
  • Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
  • Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
  • Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception

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: NCT07726212 · MC002 FIH Study · Sponsor

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗