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Набор скоро начнётся NCT07063407

Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

Фаза I С лечением Extensive Stage Small Cell Lung Cancer (ES-SCLC)

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: HS-20093 in combination with Adebrelimab.
Кому может быть актуально
Состояния в реестре: Extensive Stage Small Cell Lung Cancer (ES-SCLC). 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 Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

Обзор

This is a Phase I clinical study of HS-20093. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

Подробное описание

This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with ES-SCLC. Patients with ES-SCLC without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy) will receive maintenance therapy of HS-20093 in combination with Adebrelimab. Patients will continue treatment until disease progression or other criteria for termination of treatment are met.

Вмешательства

  • Препарат HS-20093 in combination with Adebrelimab
    HS-20093 in combination with Adebrelimab will be administered intravenously every 3 weeks until disease progression or other criteria for termination of treatment are met.

Первичные конечные точки

  • Pogression-free survival (PFS) determined by investigators according to RECIST 1.1 [Срок оценки: up to approximately 24 months]
Вторичные конечные точки (8)
  • Incidence of adverse events (AEs) [Срок оценки: From the first dose through 90 days post end of treatment]
  • Objective response rate (ORR) assessed by investigator [Срок оценки: up to approximately 24 months]
  • Disease Control Rate (DCR) [Срок оценки: up to approximately 24 months.]
  • Duration of response (DOR) [Срок оценки: up to approximately 24 months.]
  • Overall survival (OS) [Срок оценки: up to approximately 24 months.]
  • Observed maximum plasma concentration (Cmax) of HS-20093 [Срок оценки: up to approximately 24 months.]
  • Area Under the Plasma Concentration-Time Curve (AUC) of HS-20093 [Срок оценки: up to approximately 24 months.]
  • Percentage of participants with antibodies to HS-20093 in serum [Срок оценки: up to approximately 24 months.]

Критерии участия

Критерии включения

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Men or women aged more than or equal to (≥) 18 years.
  • Pathologically diagnosed as ES-SCLC.
  • Without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy).
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
  • Estimated life expectancy >12 weeks.
  • Adequate bone marrow reserve or serious organ dysfunction
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
  • Females must have evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Критерии исключения

  • Uncontrolled pleural effusion or ascites or pericardial effusion.
  • Known and untreated, or active central nervous system metastases.
  • Active autoimmune diseases or active infectious disease
  • Known to have interstitial pneumonia or immune pneumonia
  • History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20093
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
  • The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
  • History of neuropathy or mental disorders, including epilepsy and dementia.

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: NCT07063407 · HS-20093-108

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗