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Metastatic Hepatocellular CarcinomaPhase 1/2NCT06427941

A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing BGB-B2033, Tislelizumab and Bevacizumab in people with Metastatic Hepatocellular Carcinoma and Local Advanced Hepatocellular Carcinoma, run by BeOne Medicines at 51 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with advanced or metastatic hepatocellular carcinoma (HCC)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-B2033, Tislelizumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
51 sitesin 9 countries
Study dates
23 Jul 2024to 31 Oct 2028
Phase
Phase 1/2
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 one of the following unresectable, locally advanced, or metastatic tumor types:
  • Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach.
  • Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP > 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing.
  • Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist.
  • Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI).
  • At least one evaluable lesion for dose escalation, and at least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Adequate organ function as defined in the protocol.
  • Provision of tumor tissue samples is required for specified parts of the study.

Who cannot join

  • Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
  • Active leptomeningeal disease or uncontrolled/untreated brain metastases.
  • Active autoimmune disease or a history of autoimmune disease with potential for relapse.
  • Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent.
  • Requirement for systemic corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s).
  • Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.
  • Note: Additional protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

51 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

51 sites in 9 countries

China18 sites, 18 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

    Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch

    Nanchang, Jiangxi, 330038

    Recruiting

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    Nanning, Guangxi, 530201

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Recruiting

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Recruiting

Other trials in China

United States8 sites, 8 recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama, 35294-0004

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010-3012

    Recruiting

  • City of Hope Phoenix Cancer Center

    Goodyear, Arizona, 85338

    Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting

  • Scri Oncology Partners

    Nashville, Tennessee, 37203-1503

    Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

    Recruiting

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    Pittsburgh, Pennsylvania, 15232-1309

    Recruiting

  • City of Hope Chicago Cancer Center

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

South Korea8 sites, 7 recruiting

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do, 13496

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbukdo, 28644

    Recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Active, not recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

    Recruiting

Other trials in South Korea

Brazil5 sites, 5 recruiting

  • Fundacao Pio Xii Hospital de Amor de Barretos

    Barretos, 14.784-400

    Recruiting

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270

    Recruiting

  • Hospital Da Bahia

    Salvador, 41810-011

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000

    Recruiting

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000

    Recruiting

Other trials in Brazil

Italy4 sites, 4 recruiting

  • Irccs Istituto Nazionale Tumori Fondazione Pascale

    Naples, 80131

    Recruiting

  • Iov Istituto Oncologico Veneto Irccs

    Padova, 35128

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Recruiting

  • Irccs Humanitas Research Hospital

    Rozzano, 20089

    Recruiting

Other trials in Italy

France3 sites, 3 recruiting

  • Hopital Beaujon

    Clichy, 92110

    Recruiting

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44000

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Japan3 sites, 3 recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyoku, Tokyo, 113-8677

    Recruiting

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, 135-8550

    Recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Recruiting

Other trials in Japan

New Zealand1 site, 1 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

Other trials in New Zealand

Puerto Rico1 site, 1 recruiting

  • Hospital Oncologico

    Rio Piedras, 00935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 1/2 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also determine the recommended Phase 2 dose (RP2D) of BGB-B2033 when given alone or in combination with tislelizumab and bevacizumab. The main questions it aims to answer are:

  • Is BGB-B2033 safe and tolerable when given alone or in combination with tislelizumab, with or without bevacizumab?
  • How does the body process BGB-B2033, and what are its effects on the body?
  • Does BGB-B2033 show preliminary antitumor activity in participants with advanced or metastatic cancer?
Read more

Researchers will evaluate different doses and treatment combinations to determine the safest and most appropriate dose of BGB-B2033 for further study.

Participants will:

  • Receive BGB-B2033 by intravenous infusion, either alone or in combination with tislelizumab, with or without bevacizumab.
  • Have regular assessments to monitor safety, side effects, how their body processes and responds to BGB-B2033, and whether their cancer responds to treatment.
Being tested
BGB-B2033, Tislelizumab, Bevacizumab
Keywords
GPC-3, GPC3-positive squamous non-small cell lung cancer, BGB-B2033, tislelizumab, hepatocellular carcinoma, alpha-fetoprotein (AFP)-producing gastric cancer, extragonadal yolk sac tumors, Bevacizumab
Medical subject headings
Carcinoma, Hepatocellular, Simpson-Golabi-Behmel syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-B2033Drug

    Administered by intravenous infusion

  • TislelizumabDrug

    Administered by intravenous infusion

  • BevacizumabDrug

    Administered by intravenous infusion

Study groups in NCT06427941
Study groupRoleWhat they receive
Part A (Monotherapy Dose Escalation and Safety Expansion)ExperimentalParticipants will receive ascending dose levels of BGB-B2033 monotherapy
Receives: Drug: BGB-B2033
Part B (Doublet Run-in)ExperimentalParticipants will receive BGB-B2033 in combination with tislelizumab and to inform the starting dose of BGB-B2033 for subsequent triplet dose escalation.
Receives: Drug: BGB-B2033; Drug: Tislelizumab
Part B (Triplet Dose Escalation)ExperimentalParticipants will receive BGB-B2033 in combination with tislelizumab and bevacizumab to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDFE) of the combination.
Receives: Drug: BGB-B2033; Drug: Tislelizumab; Drug: Bevacizumab
Part B (Triplet and Doublet Safety Expansion)ExperimentalSafety expansion arm for each combination therapy cohort (triplet and doublet)
Receives: Drug: BGB-B2033; Drug: Tislelizumab; Drug: Bevacizumab
Part C (Asia Monotherapy Dose Expansion in HCC)ExperimentalParticipants in Asian countries with HCC will receive BGB-B2033 as monotherapy.
Receives: Drug: BGB-B2033
Part D (US Monotherapy Dose Expansion in HCC)ExperimentalParticipants in the United States (US) with HCC will receive BGB-B2033 as monotherapy.
Receives: Drug: BGB-B2033
Part E (Monotherapy Dose Expansion in HCC)ExperimentalParticipants with HCC will receive BGB-B2033 as monotherapy.
Receives: Drug: BGB-B2033

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy [ASTCT] for cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Measured: Up to approximately 2 years

  2. Part A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033

    The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.

    Measured: Up to approximately 2 years

  3. Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033

    The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration

    Measured: Up to approximately 2 years

  4. Parts C, D, and E: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Measured: Up to approximately 2 years

Secondary outcomes (11)

  1. Part A and B: Overall Response Rate (ORR) as assessed by the investigator

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Measured: Up to approximately 2 years

  2. Part A and B: Duration of Response (DOR) as assessed by the investigator

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Part A and B: Disease Control Rate (DCR) as assessed by the investigator

    DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments using RECIST v1.1.

    Measured: Up to approximately 2 years

  4. Part A and B: Progression Free Survival (PFS) as assessed by the investigator

    PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease using RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  5. Part A and B: Serum concentration of of BGB-B2033

    Measured: Up to approximately 2 years

  6. Part A and B: Number of participants with anti-drug antibodies (ADAs) to BGB-B2033

    Measured: Up to approximately 2 years

  7. Parts C, D, and E: Overall Response Rate (ORR) as assessed by the Investigator

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Measured: Up to approximately 2 years

  8. Parts C, D, and E: Duration of Response (DOR) as assessed by the investigator and IRC

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years

  9. Parts C, D, and E: Progression Free Survival (PFS) as assessed by the investigator and IRC

    PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease using RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  10. All Parts: Overall Survival (OS)

    OS is defined as the time from first dose to the death due to any cause.

    Measured: Up to approximately 2 years

  11. Parts C, D, and E: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs), characterized by type, frequency, and severity. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), and, where applicable, according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

    Events will also be described by timing of onset, seriousness, and assessed relationship to the study therapy. In addition, adverse events meeting protocol-defined adverse events of clinical interest (AECIs) will be specifically evaluated. Laboratory abnormalities will be summarized as part of the overall safety assessment.

    Measured: 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.

  1. First posted24 May 2024
  2. Study start23 Jul 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427941
Sponsor's protocol ID
BGB-B2033-101
Other IDs
2025-524136-19-00, jRCT2051260010, CTR20242917, 2025
Status last verified
Sep 2026
First submitted
20 May 2024
Last updated
16 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BGB-B2033, Tislelizumab and Bevacizumab in people with Metastatic Hepatocellular Carcinoma and Local Advanced Hepatocellular Carcinoma, run by BeOne Medicines at 51 sites in 9 countries.

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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China, United States, South Korea, Brazil, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06427941.

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 16 Sep 2026.

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