Advanced HBV-Related Hepatocellular Carcinoma
Conditions
Brief 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.
Interventions
DRUGBRII-5395
BRII-5395 will be given via IM injection
DRUGSintilimab
Sintilimab will be given via IV infusion
DRUGBevacizumab
Bevacizumab will be given via IV infusion
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant. 2. BCLC stages Intermediate (B) or Advanced (C). 3. Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies. 4. Adequate bone marrow and organ function status. 5. Life expectancy \> 3 months. 6. HBsAg \> 0.05 IU/mL at screening.
Exclusion criteria
1. Any systemic anticancer therapy within specified period prior to the first dose of study treatment. 2. Any localized anticancer therapy within specified period prior to the first dose of study treatment. 3. History of anaphylactic hypersensitivity prior to the first dose of study treatment. 4. Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab. 5. Presence of cancer or metastasis in the central nervous system with clinical symptoms. 6. Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified. 7. Current or past history of infection with HIV, HCV, or active tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and type of dose-limiting toxicities (DLTs) | Up to 30 days post last dose |
| Adverse events (AEs) and serious AEs (SAEs) | Up to 30 days post last dose |
| Abnormalities in laboratory and other clinical assessments | Up to 30 days post last dose |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to 2 years |
| Disease control rat (DCR) | Up to 2 years |
| Duration of response (DOR) | Up to 2 years |
| Progression-free survival (PFS) | Up to 2 years |
| Overall survival (OS) | Up to 2 years |
Countries
China
Contacts
CONTACTNing Li, Dr.
CONTACTShuhang Wang, Dr.
STUDY_DIRECTORShuhang Wang, Dr.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed