Phase 2
Completed N=94
A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
Source: ClinicalTrials.gov NCT04948697 ↗Enrolled (actual)
94
Serious AEs
46.2%
Results posted
Feb 2025
Primary outcomePrimary: Objective Response Rate (ORR) as Assessed by the Investigator — 37.1; 40.6 percentage of participants
Summary
This was 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 Hepatocellular Carcinoma (HCC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) as Assessed by the Investigator |
37.1; 40.6 | — |
| SECONDARY Duration Of Response (DOR) as Assessed by the Investigator |
12.6; 12.4 | — |
| SECONDARY Time to Response (TTR) as Assessed by the Investigator |
2.76; 4.17 | — |
| SECONDARY Disease Control Rate (DCR) as Assessed by the Investigator |
77.4; 71.9 | — |
| SECONDARY Clinical Benefit Rate (CBR) as Assessed by the Investigator |
59.7; 56.3 | — |
| SECONDARY Progression-Free Survival (PFS) as Assessed by the Investigator |
8.3; 6.9 | — |
| SECONDARY Overall Survival (OS) |
19.7; 22.9 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
62; 31; 31; 12; 48; 17 | — |
| SECONDARY Serum Concentrations of Ociperlimab |
0.00; 287.15; 39.82; 68.23; 385.22; 79.83 | — |
| SECONDARY Serum Concentrations of Tislelizumab |
0.00; 0.00; 69.63; 67.69; 19.65; 17.70 | — |
| SECONDARY Serum Concentrations of BAT1706 |
0.00; 0.00; 319.29; 321.03; 63.28; 55.30 | — |
| SECONDARY Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 |
1; 0; 1; 22; 18; 1 | — |
Eligibility Criteria
Criteria:
Inclusion Criteria
- Histologically confirmed HCC
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease that was not amenable to or had progressed after loco-regional therapy, and was not amenable to a curative treatment approach
- Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (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
- 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
Data sourced from ClinicalTrials.gov (NCT04948697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.