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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

NCT07557251 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

  • Advanced HBV-Related Hepatocellular Carcinoma

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

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Shuhang Wang, Dr. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07557251 on ClinicalTrials.gov