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Идёт набор NCT07028281

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors

Фаза II С лечением Malignant 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: SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin.
Кому может быть актуально
Состояния в реестре: Malignant Solid Tumors. 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
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Официальное название

A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors

Обзор

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.

Вмешательства

  • Препарат SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
    SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Первичные конечные точки

  • DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage) [Срок оценки: up to 21 days]
  • Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage) [Срок оценки: up to 24 months]
  • Objective Response Rate (ORR) as Assessed by investigators(The second stage) [Срок оценки: up to 24 months]
Вторичные конечные точки (10)
  • ORR(The first stage) [Срок оценки: up to 24 months]
  • DoR(The first stage) [Срок оценки: up to 24 months]
  • DCR(The first stage) [Срок оценки: up to 24 months]
  • PFS(The first stage) [Срок оценки: up to 24 months]
  • OS(The first stage) [Срок оценки: up to 30 months]
  • DoR(The second stage) [Срок оценки: up to 24 months]
  • DCR(The second stage) [Срок оценки: up to 24 months]
  • PFS(The second stage) [Срок оценки: up to 24 months]
  • OS(The second stage) [Срок оценки: up to 30 months]
  • Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The second stage) [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

  • Subject has provided informed consent prior to initiation of any study-procedures
  • Age from 18 to 75 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed solid tumors
  • At least one measurable lesion was identified per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Has a life expectancy of at least 3 months.
  • Adequate organ function
  • Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug

Критерии исключения

  • Subjects with active central nervous system (CNS) metastasis.
  • Subjects with a history of malignant tumors within 5 years prior to the first dose
  • Subjects with uncontrolled cancer pain.
  • Subjects with severe cardiovascular disease.
  • Subjects with clinically significant hemorrhage
  • Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
  • Subjects highly suspected of interstitial lung disease
  • Subjects with serious infection within 4 weeks prior to the first dose
  • Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
  • The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
  • Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
  • Subjects who received major surgery within 4 weeks prior to the first dose
  • Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
  • Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
  • Known allergic to any component of investigational drugs
  • Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
  • Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,

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 · 1 центр
  • Affiliated Cancer Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT07028281 · SHR-4849-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗