A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors

Официальное название

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4506 Injection in Patients With Malignant Tumors

Обзор

The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Вмешательства

• Препарат SHR-4506 Injection
  SHR-4506 injection.

Первичные конечные точки

• Dose Limited Toxicities (DLTs) [Срок оценки: Up to 21 days.]
• Maximum Tolerated Dose (MTD) [Срок оценки: Up to 21 days.]
• Incidence and severity of adverse events (AEs) [Срок оценки: Up to 90 days after the last dose.]
• Incidence and severity of serious adverse events (SAEs) [Срок оценки: Up to 90 days after the last dose.]

Вторичные конечные точки (5)

• Objective response rate (ORR) assessed by the investigator [Срок оценки: Up to 3 years.]
• Objective tumor response duration (DoR) [Срок оценки: Up to 3 years.]
• Disease control rate (DCR) [Срок оценки: Up to 3 years.]
• Progression free survival (PFS) [Срок оценки: Up to 3 years.]
• Overall survival (OS) [Срок оценки: Up to 3 years.]

Критерии участия

Критерии включения

• Age ≥18 years, any gender.
• ECOG performance status 0-1.
• Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
• Adequate organ function.
• Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
• Expected survival ≥12 weeks.
• Patients in the dose-expansion phase must have measurable lesions.
• Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.

Критерии исключения

• Prior treatment with the same class of investigational drug.
• Confirmed or suspected central nervous system (CNS) tumor involvement.
• Uncontrolled tumor-related pain.
• Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
• Clinically significant cardiovascular disease history.
• Known hypersensitivity to any component of the investigational drug.
• Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
• Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
• Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
• History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
• Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
• Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.

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 · 2 центра

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай
• Renji Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07068932 · SHR-4506-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗