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NCT Number: NCT07557251

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

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.

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Key information

Conditions

Advanced HBV-Related Hepatocellular Carcinoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location contact

Ning Li, Dr.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BRII-5395

Drug

BRII-5395 will be given via IM injection

Sintilimab

Drug

Sintilimab will be given via IV infusion

Bevacizumab

Drug

Bevacizumab will be given via IV infusion

Primary outcomes

  1. Incidence and type of dose-limiting toxicities (DLTs)

    Time frame: Up to 30 days post last dose

  2. Adverse events (AEs) and serious AEs (SAEs)

    Time frame: Up to 30 days post last dose

  3. Abnormalities in laboratory and other clinical assessments

    Time frame: Up to 30 days post last dose

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

  2. Disease control rat (DCR)

    Time frame: Up to 2 years

  3. Duration of response (DOR)

    Time frame: Up to 2 years

  4. Progression-free survival (PFS)

    Time frame: Up to 2 years

  5. Overall survival (OS)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ning Li, Dr.

CONTACT

[email protected]

+8601087788713

Shuhang Wang, Dr.

CONTACT

[email protected]

+8613581809307

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.