A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
About the study
This is a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced HCC.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Histologically confirmed HCC
- BCLC Stage C disease, or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy, and is not amenable to a curative treatment approach
- Tumor tissue required for an evaluable PD-L1 expression result
- No prior systemic therapy for HCC
- At least 1 measurable lesion as defined per RECIST v1.1
- Adequate organ function during screening and before randomization
EXCLUSION CRITERIA
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
- Prior history of ≥ Grade 2 hepatic encephalopathy
- Leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
- Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
- Prior allogeneic stem cell transplantation or organ transplantation
- Significant cardiovascular risk factors
- Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Administered a live vaccine ≤ 28 days before randomization
NOTE: Other protocol Inclusion/Exclusion criteria may apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Hepatocellular Carcinoma
Age (in years)
18+
Phase
Phase 2
Participants needed
90
Est. Completion Date
Mar 31, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT04948697
Study number
AdvanTIG-206
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