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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRII-5395, Sintilimab, Bevacizumab.
- Who it may be relevant to
- Registry conditions: Advanced HBV-Related Hepatocellular Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug BRII-5395
BRII-5395 will be given via IM injection - Drug Sintilimab
Sintilimab will be given via IV infusion - Drug Bevacizumab
Bevacizumab will be given via IV infusion
Primary outcome measures
- Incidence and type of dose-limiting toxicities (DLTs) [Time frame: Up to 30 days post last dose]
- Adverse events (AEs) and serious AEs (SAEs) [Time frame: Up to 30 days post last dose]
- Abnormalities in laboratory and other clinical assessments [Time frame: Up to 30 days post last dose]
Secondary outcome measures (5)
- Objective response rate (ORR) [Time frame: Up to 2 years]
- Disease control rat (DCR) [Time frame: Up to 2 years]
- Duration of response (DOR) [Time frame: Up to 2 years]
- Progression-free survival (PFS) [Time frame: Up to 2 years]
- Overall survival (OS) [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07557251 · BRII-5395-001