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RecruitingNCT07557251Updated Aug 31, 2026

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

A Phase 1 interventional study of BRII-5395 and Sintilimab in Advanced HBV-Related Hepatocellular Carcinoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Advanced HBV-Related Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Any systemic anticancer therapy within specified period prior to the first dose of study treatment.
  2. Any localized anticancer therapy within specified period prior to the first dose of study treatment.
  3. History of anaphylactic hypersensitivity prior to the first dose of study treatment.
  4. Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.
  5. Presence of cancer or metastasis in the central nervous system with clinical symptoms.
  6. Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
  7. Current or past history of infection with HIV, HCV, or active tuberculosis.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (estimated)

Study arms

  • Experimental
    BRII-5395 dose escalation

    Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.

    Drug: BRII-5395 · Drug: Sintilimab · Drug: Bevacizumab

  • Experimental
    BRII-5395 dose expansion

    Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.

    Drug: BRII-5395 · Drug: Sintilimab · Drug: Bevacizumab

Interventions

  • DrugBRII-5395

    BRII-5395 will be given via IM injection

  • DrugSintilimab

    Sintilimab will be given via IV infusion

  • DrugBevacizumab

    Bevacizumab will be given via IV infusion

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    Beijing, China
    • Ning Li, Dr. · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07557251
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
Aug 12, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 31, 2026

Study contacts

Ning Li, Dr.
Contact
lining@cicams.ac.cn
+8601087788713
Shuhang Wang, Dr.
Contact
wangshuhang@cicams.ac.cn
+8613581809307
Shuhang Wang, Dr.
study director · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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