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
Study ID
NCT07557251
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced HBV-Related Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • BRII-5395 — DRUG
    BRII-5395 will be given via IM injection
  • Sintilimab — DRUG
    Sintilimab will be given via IV infusion
  • Bevacizumab — DRUG
    Bevacizumab will be given via IV infusion

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Aug 12, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BRII-5395 dose escalation
    Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
  • Experimental: BRII-5395 dose expansion
    Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.

Primary Outcome Measure

Incidence and type of dose-limiting toxicities (DLTs) [ Time Frame: Up to 30 days post last dose ]

Central Contacts