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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
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
BRII-5395
BRII-5395 will be given via IM injection
Sintilimab
Sintilimab will be given via IV infusion
Bevacizumab
Bevacizumab will be given via IV infusion
Locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China