Hepatocellular CancerPhase 2NCT07911683
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
A Phase 2 study testing BGB-B2033 in people with Hepatocellular Cancer and Liver Cancer, run by BeOne Medicines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer, Liver Cancer, Hepatocellular Carcinoma
- What is being tested?
- BGB-B2033
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function, as determined by laboratory tests performed during screening.
- Participants must be willing to use effective birth control during the study, as required by the study protocol.
Who cannot join
- Previous treatment targeting glypican-3 (GPC3) or 4-1BB.
- Active leptomeningeal disease or uncontrolled and untreated brain metastases.
- A history of previous or current encephalopathy, a condition that affects brain function.
- Radiographic evidence of tumor thrombosis involving the inferior vena cava or right atrium of the heart.
- A history of liver transplantation.
- Presence of clinically significant ascites (≥ Grade 2)
- Untreated chronic hepatitis B or chronic HVB carries with HVB DNA > 2000 IU/mL at screening
- Note: Other eligibility criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2 Global, Single-Arm Study of BGB-B2033 Monotherapy in Patients With Hepatocellular Carcinoma Previously Treated With Anti-PD-1/PD-L1 Therapies
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.
Read the detailed description
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
- Being tested
- BGB-B2033
- Keywords
- Hepatocellular Carcinoma, BGB-B2033, Hepatocellular Cancer, GPC3
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-B2033Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| BGB-B2033 Monotherapy | Experimental | Participants will receive BGB-B2033 intravenously until progressive disease, unacceptable toxicity, or withdrawal of consent. Receives: Drug: BGB-B2033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 15 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From first dose of study drug to 90 days after last dose; up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911683
- Sponsor's protocol ID
- BGB-B2033-201
- Other IDs
- 2026-528408-32-00, GroundBBreaker 201
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Global, Single-Arm Study of BGB-B2033 Monotherapy in Patients With Hepatocellular Carcinoma Previously Treated With Anti-PD-1/PD-L1 Therapies
- ClinicalTrials.gov ID
- NCT07911683
- Acronym / sponsor ID
- BGB-B2033-201
- Keywords
- Hepatocellular Carcinoma, BGB-B2033, Hepatocellular Cancer, GPC3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGB-B2033 Monotherapy | Experimental | Drug: BGB-B2033Participants will receive BGB-B2033 intravenously until progressive disease, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
- 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).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function, as determined by laboratory tests performed during screening.
Key exclusion criteria (8 listed)
- Previous treatment targeting glypican-3 (GPC3) or 4-1BB.
- Active leptomeningeal disease or uncontrolled and untreated brain metastases.
- A history of previous or current encephalopathy, a condition that affects brain function.
- Radiographic evidence of tumor thrombosis involving the inferior vena cava or right atrium of the heart.
- A history of liver transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-B2033Administered intravenously | Drug | BGB-B2033 Monotherapy |
Primary outcome
Overall Response Assessment (ORR) by Independent Review Committee Assessment
Time frame: Up to approximately 15 months
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.
5 secondary outcomes
Duration of Response (DOR)
Time frame: Up to approximately 2 years
ORR by Investigator Assessment
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-Mediated Adverse Events (iMAEs)
Time frame: From first dose of study drug to 90 days after last dose; up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGB-B2033 in people with Hepatocellular Cancer and Liver Cancer, run by BeOne Medicines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Assessment (ORR) by Independent Review Committee Assessment (time frame: Up to approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.