A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors

Официальное название

A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors

Обзор

This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.

Вмешательства

• Препарат SHR-7787 Injection
  SHR-7787 Injection.
• Препарат SHR-1316 Injection
  SHR-1316 Injection.
• Препарат SHR-4849 Injection
  SHR-4849 Injection.
• Препарат Etoposide injection
  Etoposide Injection.
• Препарат Carboplatin injection
  Carboplatin Injection.
• Препарат Cisplatin injection
  Cisplatin Injection.
• Препарат BP102 Injection
  BP102 Injection.

Первичные конечные точки

• The Recommended phase II dose of SHR-7787 injection monotherapy (stage I) [Срок оценки: Expected to be two years after the start of the study.]
• Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) [Срок оценки: About 1 year after study initiation.]
• Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) [Срок оценки: About 1 year after study initiation.]
• Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I) [Срок оценки: About 1 year after study initiation.]
• Objective response rate (ORR) (stage II) [Срок оценки: Expected to be two years after the start of the study.]
• Progress Free Survival (FPS) (stage II) [Срок оценки: Expected to be two years after the start of the study.]

Вторичные конечные точки (5)

• Objective response rate (ORR) [Срок оценки: About 1 year.]
• Duration of Response (DoR) [Срок оценки: About 1 year.]
• Disease Control Rate (DCR) [Срок оценки: About 1 year.]
• Progress Free Survival (PFS) [Срок оценки: About 1 year.]
• Overall Survival (OS) [Срок оценки: About 1 year.]

Критерии участия

Критерии включения

• Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
• Patients with histologically or cytologically confirmed unresectable solid tumors;
• At least one measurable lesion was identified per RECIST 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Adequate organ functions as defined per protocol;
• Minimum life expectancy of 3 months.

Критерии исключения

• Patients with known active central nervous system (CNS) metastases;
• History of other malignancy within the past 5 years, with exceptions defined in the protocol;
• Patients with uncontrolled cancer pain;
• Patients with serious cardiovascular and/or cerebrovascular diseases;
• Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
• Patients with Severe infections within 4 weeks prior to the first dose;
• Active pulmonary tuberculosis infection;
• History of immunodeficiency;
• History of autoimmune diseases;
• The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
• Pregnant or nursing women, or planned to become pregnant during the study period;
• Known allergic to any component of investigational drugs.

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

• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & T — Ухань
• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07268040 · SHR-7787-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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