← Back to all trials
Not Yet Recruiting
NCT07911683
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Conditions: Hepatocellular Cancer, Liver Cancer, Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: BeOne Medicines
Summary
The purpose of this study is to evaluate the efficacy and safety of BGB-B2033 monotherapy in adults with hepatocellular carcinoma who have previously been treated with anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapies.
Eligibility Criteria
Inclusion Criteria
1. Participants must have histologically confirmed hepatocellular carcinoma (HCC) that cannot be treated with curative surgery or locoregional therapy (LRT), or have disease that has progressed after surgery and/or locoregional therapy.
2. Participants must have documented disease progression or intolerance after at least one prior line of systemic therapy containing an anti-programmed cell death protein 1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) therapy.
3. Participants must have at least one measurable tumor lesion, as assessed according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
4. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. Participants must have adequate organ function, as determined by laboratory tests performed during screening.
6. Participants must be willing to use effective birth control during the study, as required by the study protocol.
Exclusion Criteria
1. Previous treatment targeting glypican-3 (GPC3) or 4-1BB.
2. Active leptomeningeal disease or uncontrolled and untreated brain metastases.
3. A history of previous or current encephalopathy, a condition that affects brain function.
4. Radiographic evidence of tumor thrombosis involving the inferior vena cava or right atrium of the heart.
5. A history of liver transplantation.
6. Presence of clinically significant ascites (≥ Grade 2)
7. Untreated chronic hepatitis B or chronic HVB carries with HVB DNA \> 2000 IU/mL at screening
Note: Other eligibility criteria may apply.
Source: ClinicalTrials.gov (NCT07911683). StuddyBuddy aggregates publicly available trial information.