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Набор скоро начнётся NCT07687914

A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Hepatocellular Carcinoma

Фаза II С лечением HCC - Hepatocellular Carcinoma

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: IMM2510, IMM27M.
Кому может быть актуально
Состояния в реестре: HCC - Hepatocellular Carcinoma. 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
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

Phase II Clinical Study of IMM2510 for Injection Combined With IMM27M for Injection in Advanced Hepatocellular Carcinoma

Обзор

This is a Phase 2, open-label, multicenter,study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant - Page 1 of 5 - protein) combine with IMM27M(Anti-CTLA-4 Humanized monoclonal antibody) in patients with advanced hepatocellular carcinoma who not have received the treatment for aHCC in past

Вмешательства

  • Препарат IMM2510, IMM27M
    Biological/Vaccine: IMM2510 IMM2510 administered intravenously once every 2 weeks ( 20 mg/kg Q2W). Biological/Vaccine: IMM01 IMM01 administered intravenously once every 2 weeks ( 1 mg/kg Q8W).

Первичные конечные точки

  • Objective Response Rate (ORR) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years]
Вторичные конечные точки (7)
  • Disease Control Rate(DCR) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years]
  • Duration of Response (DOR) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years]
  • Progression- Free Survival(PFS) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • Overall Survival(OS) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0) [Срок оценки: From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment]
  • Maximum Plasma Concentration [Cmax] [Срок оценки: through study completion, an average of 1 year]
  • Area Under the Curve from time 0 to time t（AUC0-t） [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

Participant has provided informed consent prior to initiation of any study specific activities/procedures.

  • Age greater than or equal to 18 years old and ≤ 75 years old at the same time of signing the informed consent.
  • Histologically or cytologically confirmed for HCC
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Adequate organ function as defined in protocol.

Критерии исключения

  • History of other malignancy within the past 5 years with exceptions.
  • Systemic chemotherapy was administered within 4 weeks prior to the first administration.
  • Activated symptomatic brain metastases and leptomeningeal disease.
  • History of hepatic encephalopathy disease in past 12 months.
  • Participants with symptoms and/or clinical signs and/or uncontrolled active systemic infection within 14 days prior to the first dose of study treatment. Participant has known active infection requiring parenteral antibiotic treatment.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07687914 · Immuneonco company

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗