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NOT YET RECRUITING
NCT07557251
PHASE1

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-05

Completion Date

2028-12

Last Updated

2026-05-06

Healthy Volunteers

No

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

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China