A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Advanced Hepatitis B Virus Related Hepatocellular Carcinoma

Официальное название

An Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Participants With Advanced Hepatitis B Virus Related Hepatocellular Carcinoma

Обзор

This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus (HBV) infection. The primary objective of the study is to assess the safety and tolerability of the combination therapy, as well as to explore preliminary evidence of clinical benefit.

Вмешательства

• Препарат BRII-5395
  BRII-5395 will be given via IM injection
• Препарат Sintilimab
  Sintilimab will be given via IV infusion
• Препарат Bevacizumab
  Bevacizumab will be given via IV infusion

Первичные конечные точки

• Incidence and type of dose-limiting toxicities (DLTs) [Срок оценки: Up to 30 days post last dose]
• Adverse events (AEs) and serious AEs (SAEs) [Срок оценки: Up to 30 days post last dose]
• Abnormalities in laboratory and other clinical assessments [Срок оценки: Up to 30 days post last dose]

Вторичные конечные точки (5)

• Objective response rate (ORR) [Срок оценки: Up to 2 years]
• Disease control rat (DCR) [Срок оценки: Up to 2 years]
• Duration of response (DOR) [Срок оценки: Up to 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years]
• Overall survival (OS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant.
• BCLC stages Intermediate (B) or Advanced (C).
• Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies.
• Adequate bone marrow and organ function status.
• Life expectancy > 3 months.
• HBsAg > 0.05 IU/mL at screening.

Критерии исключения

• Any systemic anticancer therapy within specified period prior to the first dose of study treatment.
• Any localized anticancer therapy within specified period prior to the first dose of study treatment.
• History of anaphylactic hypersensitivity prior to the first dose of study treatment.
• Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.
• Presence of cancer or metastasis in the central nervous system with clinical symptoms.
• Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
• Current or past history of infection with HIV, HCV, or active tuberculosis.

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 · 1 центр

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07557251 · BRII-5395-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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