drugset / Trial / NCT07557251
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
Phase 1
Not yet recruiting
21 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BRII-5395 | Unknown | — | Intramuscular |
| Background | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |