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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Bevacizumab

Criteria

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