A Phase 2 interventional study of BGB-B2033 in Hepatocellular Cancer, Liver Cancer and Hepatocellular Carcinoma, sponsored by BeOne Medicines. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by BeOne Medicines · Phase 2, Interventional, and Treatment
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.
Hepatocellular Carcinoma (HCC) is the most common type of liver cancer. It can develop when abnormal cells in the liver grow uncontrollably and may spread to other parts of the body. Current treatment options are limited for people with HCC whose disease has progressed or who cannot tolerate treatment after receiving therapies that target PD-1 or PD-L1.
BGB-B2033 is a new experimental drug that attaches to a protein called glypican-3 (GPC3), a protein found on the surface of many liver cancer cells, and also binds to cells of the immune system, helping the immune system to recognize and attack the cancer cells.
This study will test whether BGB-B2033 is safe to treat HCC. The main purpose of this study is to find out how well BGB-B2033 works against HCC and to learn more about its safety. Everyone who takes part in the study will receive BGB-B2033 as the only study treatment. There is no comparison or placebo group. This is also an open-label study, which means that both participants and the study doctors will know that BGB-B2033 is being given.
BGB-B2033 will be administered by intravenous infusion every 3 weeks.
The study will enroll approximately 100 adults at multiple centers worldwide with hepatocellular carcinoma that cannot be treated with curative surgery or local treatments, or that has progressed after surgery or local treatment. Participants must have previously received at least one systemic treatment containing an anti-PD-1 or anti-PD-L1 therapy.
The overall time to participate in this study will vary depending on how long participants receive treatment and follow-up but is expected to be around 24 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests, monitoring for side effects, and tumor imaging tests
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 100 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →BeOne Medicines is the lead sponsor of 68 studies on the registry; 48 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Carcinoma, Hepatocellular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Liver Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Note: Other eligibility criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive BGB-B2033 intravenously until progressive disease, unacceptable toxicity, or withdrawal of consent.
Drug: BGB-B2033
Administered intravenously
Overall Response Assessment (ORR) by Independent Review Committee Assessment
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) with confirmation per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on Independent Review Committee (IRC) assessments.
Time frame: Up to approximately 15 months
Duration of Response (DOR)
DOR is defined as the time from the first documented response to documented disease progression or death, whichever comes first, based on IRC and investigator assessments
Time frame: Up to approximately 2 years
ORR by Investigator Assessment
ORR is defined as the percentage of participants with best overall response of CR or PR with confirmation per RECIST V1.1
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
PFS is defined as the time from first dose to documented disease progression per RECIST 1.1 or death, whichever occurs first, with separate derivations based on IRC and investigator assessments
Time frame: Up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from first dose of study drug to death due to any cause.
Time frame: Up to approximately 2 years
Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-Mediated Adverse Events (iMAEs)
An adverse event is any unfavorable or unintended sign, symptom, disease, or abnormal laboratory finding that occurs during the study, whether or not it is related to the study drug. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, results in a congenital anomaly or birth defect, or is medically significant based on the judgment of the study doctor or sponsor. An immune-mediated adverse event (iMAE) is an adverse event caused by an immune system response that may affect organs or tissues and requires appropriate monitoring and management.
Time frame: From first dose of study drug to 90 days after last dose; up to approximately 2 years
No study locations are listed for this record.
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anti-GPC3/Anti-4-1BB Bispecific Antibody BGB-B2033