A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

Официальное название

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

Обзор

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Вмешательства

• Препарат SHR-1826
  SHR-1826 for injection.
• Препарат SHR-1316
  SHR-1316 for injection.
• Препарат SHR-9839
  SHR-9839 for injection.
• Препарат SHR-8068
  SHR-8068 for injection.
• Препарат Ametinib mesylate
  Ametinib mesylate.
• Препарат BP-102
  BP-102 for injection.
• Препарат Carboplatin
  Carboplatin for injection.

Первичные конечные точки

• Recommended phase II dose (RP2D) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Adverse events (AEs) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Objective response rate (ORR) [Срок оценки: Screening up to study completion, an average of 1 year.]

Вторичные конечные точки (7)

• Disease control rate (DCR) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Duration of response (DoR) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Progression-free survival (PFS) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Overall survival (OS) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Drug resistant antibody (ADA) to SHR-1826 [Срок оценки: Screening up to study completion, an average of 1 year.]
• Blood concentration of SHR-1826 [Срок оценки: Screening up to study completion, an average of 1 year.]
• Blood concentration of free toxin [Срок оценки: Screening up to study completion, an average of 1 year.]

Критерии участия

Критерии включения

• Voluntary participation and written informed consent.
• 18-75 years older, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 3 months.
• Pathologically diagnosed NSCLC.
• Be able to provide fresh or archived tumour tissue.
• At least one measurable lesion according to RECIST v1.1.
• Adequate organ function.
• Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Критерии исключения

• Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
• Previous or co-existing malignancies.
• Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
• Uncontrollable tumor-related pain.
• Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
• Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
• Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
• With poorly controlled or severe cardiovascular disease.
• Active hepatitis B and hepatitis C.
• Patients with a history of immunodeficiency.
• Severe infection 30 days before the first dose.

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

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06754930 · SHR-1826-201-LC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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