NCT07557251

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
32mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2028

First Submitted

Initial submission to the registry

April 7, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

April 7, 2026

Last Update Submit

April 30, 2026

Conditions

Advanced HBV-Related Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Incidence and type of dose-limiting toxicities (DLTs)

    Up to 30 days post last dose

  • Adverse events (AEs) and serious AEs (SAEs)

    Up to 30 days post last dose

  • Abnormalities in laboratory and other clinical assessments

    Up to 30 days post last dose

Secondary Outcomes (5)

  • Objective response rate (ORR)

    Up to 2 years

  • Disease control rat (DCR)

    Up to 2 years

  • Duration of response (DOR)

    Up to 2 years

  • Progression-free survival (PFS)

    Up to 2 years

  • Overall survival (OS)

    Up to 2 years

Study Arms (2)

BRII-5395 dose escalation

EXPERIMENTAL

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-5395Drug: SintilimabDrug: Bevacizumab

BRII-5395 dose expansion

EXPERIMENTAL

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-5395Drug: SintilimabDrug: Bevacizumab

Interventions

BRII-5395DRUG

BRII-5395 will be given via IM injection

BRII-5395 dose escalationBRII-5395 dose expansion
SintilimabDRUG

Sintilimab will be given via IV infusion

BRII-5395 dose escalationBRII-5395 dose expansion
BevacizumabDRUG

Bevacizumab will be given via IV infusion

BRII-5395 dose escalationBRII-5395 dose expansion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Interventions

sintilimabBevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Shuhang Wang, Dr.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Ning Li, Dr.

CONTACT

+8601087788713lining@cicams.ac.cn

Shuhang Wang, Dr.

CONTACT

+8613581809307wangshuhang@cicams.ac.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 29, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)