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NCT06427941RecruitingPhase 1/2

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 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

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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? 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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
630 (estimated)
First submitted
20 May 2024
Start date
23 Jul 2024
Primary completion date
31 Mar 2027
Lead sponsor
BeOne Medicines
NCT number
NCT06427941
EU CT number
2025-524136-19-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 630
  • From 23 Jul 2024 to the primary completion date, 31 Mar 2027
  • 50 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
  • 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).

Other illness

  • Active leptomeningeal disease or uncontrolled/untreated brain metastases.
  • Active autoimmune disease or a history of autoimmune disease with potential for relapse.
  • 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.

Who the study is looking for

  • 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundacao Pio Xii Hospital de Amor de Barretos
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BarretosBrazilRecruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
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Porto AlegreBrazilRecruiting
Hospital Da Bahia
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SalvadorBrazilRecruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São José do Rio PretoBrazilRecruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
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São PauloBrazilRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Sichuan Cancer Hospital and Institute
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ChengduChinaRecruiting
Chongqing University Cancer Hospital
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ChongqingChinaRecruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaRecruiting
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaRecruiting
Nanfang Hospital of Southern Medical University
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GuangzhouChinaRecruiting
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaRecruiting
Anhui Provincial Hospital
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HefeiChinaRecruiting
Lishui Central Hospital
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LishuiChinaRecruiting
The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch
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NanchangChinaRecruiting
The Second Affiliated Hospital of Nanchang University
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NanchangChinaRecruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
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NanningChinaRecruiting
The Fourth Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaRecruiting
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
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WuhanChinaRecruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
Hopital Beaujon
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ClichyFranceRecruiting
Centre Hospitalier Universitaire Nantes Hotel Dieu
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NantesFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
IOV - Istituto Oncologico Veneto IRCCS
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PadovaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli
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RomaItalyRecruiting
IRCCS Humanitas Research Hospital
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RozzanoItalyRecruiting
Tokyo Metropolitan Komagome Hospital
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BunkyokuJapanRecruiting
Cancer Institute Hospital of JFCR
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KōtokuJapanRecruiting
Kindai University Hospital
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SakaiJapanRecruiting
Cha Bundang Medical Center, Cha University
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BundangGu SeongnamSiSouth KoreaRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Samsung Medical Center
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GangnamGuSouth KoreaRecruiting
Severance Hospital Yonsei University Health System
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SeodaemunGuSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SongpaGuSouth KoreaRecruiting
Auckland City Hospital
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AucklandNew ZealandRecruiting
Hospital Oncologico
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Rio PiedrasPuerto RicoRecruiting
University of Alabama At Birmingham Hospital
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BirminghamUnited StatesRecruiting
City of Hope National Medical Center
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DuarteUnited StatesRecruiting
City of Hope Phoenix Cancer Center
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GoodyearUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center Mskcc
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New YorkUnited StatesRecruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
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PittsburghUnited StatesRecruiting
City of Hope Chicago Cancer Center
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ZionUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.