Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

Официальное название

A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma

Обзор

This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Вмешательства

• Препарат SHR2554 Tablets
  Oral SHR2554 tablets.
• Препарат SHR-A1811 Injection
  SHR-A1811 for injection.
• Препарат SHR-A1904 Injection
  SHR-A1904 for injection.
• Препарат SHR-1701 Injection
  SHR-1701 injection

Первичные конечные точки

• Incidence and severity of adverse events (AEs). [Срок оценки: Up to approximately 2 years.]
• Incidence and severity of serious adverse events (SAEs). [Срок оценки: Up to approximately 2 years.]
• Incidence of Dose Limited Toxicity (DLT). [Срок оценки: Up to Day 21.]
• Objective response rate (ORR) by the investigator assessment. [Срок оценки: Up to approximately 1 year.]

Вторичные конечные точки (4)

• Duration of objective tumor response (DoR). [Срок оценки: Approximately 24 months.]
• Disease control rate (DCR). [Срок оценки: Approximately 24 months.]
• Progression-free survival (PFS). [Срок оценки: Approximately 24 months.]
• Overall survival (OS) assessed by the investigator. [Срок оценки: Approximately 24 months.]

Критерии участия

Критерии включения

• At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
• Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.
• Is willing to provide an adequate tumor sample.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.

Критерии исключения

• Presence of dysphagia or other factors impairing oral administration of SHR2554.
• Has previously been treated with any enhancer of zeste homolog inhibitors.
• Uncontrolled or significant cardiovascular disease.
• Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
• Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
• History of known hypersensitivity to SHR2554 or excipients.
• Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.
• Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.
• Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.
• Psychological, social, familial, or geographical factors that would prevent regular follow-up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Harbin Medical University Cancer Hospital — Харбин
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT07102901 · SHR2554-203-GC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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