For Healthcare Professionals

A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC

clipboard-pencil

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically confirmed HCC
  2. 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
  3. Tumor tissue required for an evaluable PD-L1 expression result
  4. No prior systemic therapy for HCC
  5. At least 1 measurable lesion as defined per RECIST v1.1
  6. Adequate organ function during screening and before randomization

EXCLUSION CRITERIA

  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  2. Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
  3. Prior history of ≥ Grade 2 hepatic encephalopathy
  4. Leptomeningeal disease or uncontrolled, untreated brain metastasis
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse
  6. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
  7. Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
  8. Prior allogeneic stem cell transplantation or organ transplantation
  9. Significant cardiovascular risk factors
  10. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
  11. History of severe hypersensitivity reactions to other monoclonal antibodies
  12. Administered a live vaccine ≤ 28 days before randomization NOTE: Other protocol Inclusion/Exclusion criteria may apply
pin location

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.
Phone iconCall +1-877-828-5568Email iconEmail Study Center

Study’s details


Contition

Advanced Hepatocellular Carcinoma

Age

18+

Phase

Phase 2

Participants needed

90

Est. Completion Date

Aug 2023

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT04948697

Study number

AdvanTIG-206

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.