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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
BRII-5395 will be given via IM injection
Sintilimab will be given via IV infusion
Bevacizumab will be given via IV infusion
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Incidence and type of dose-limiting toxicities (DLTs)
Time frame: Up to 30 days post last dose
Adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 30 days post last dose
Abnormalities in laboratory and other clinical assessments
Time frame: Up to 30 days post last dose
Objective response rate (ORR)
Time frame: Up to 2 years
Disease control rat (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
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