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Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Relapsed Hepatocellular Carcinoma

21 de setembro de 2026 atualizado por: BeOne Medicines

A Randomized, Open-Label, Phase 3 Study to Investigate the Efficacy and Safety of BGB-B2033 Compared With Investigator Choice of Sorafenib or Lenvatinib in Patients With Hepatocellular Carcinoma That Progressed Upon Prior Systemic Treatment

The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines. Researchers will compare BGB-B2033 with either sorafenib or lenvatinib chosen by the study doctor to see which treatment works better and is safer.

The main questions it aims to answer are:

  • Does BGB-B2033 help control or slow the growth of liver cancer?
  • What medical problems or side effects do participants have while taking BGB-B2033?
  • Does BGB-B2033 help to prolong the survival for liver cancer participants over Lenvatinib/sorafenib?

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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. For people whose cancer has returned or continued to grow after treatment, additional treatment options are needed.

BGB-B2033 is a new investigational drug designed to bind to a protein called glypican-3 (GPC3), a protein found on certain cancer cells and cells of the immune system, helping the immune system to recognize and attack the cancer cells. Lenvatinib and sorafenib are approved medicines that work by blocking signals that help cancer cells grow and form new blood vessels.

The purpose of this study is to test whether BGB-B2033 is safe and can help treat HCC in adults whose cancer has been treated with up to 2 previous treatments that included programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) medicines. The main goal of the study is to see how well BGB-B2033 controls cancer compared to the treatments selected by the study doctor (either lenvatinib or sorafenib).

This study has 2 treatment groups. Participants will be randomly assigned, like flipping a coin, to receive either:

  • BGB-B2033, given by intravenous infusion.
  • Sorafenib, taken by mouth or lenvatinib, taken by mouth per their doctor's choice The study will enroll approximately 492 adults with HCC at multiple centers worldwide. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.

The overall study will last about 3.5 years, not including the screening period.

Tipo de estudo

Intervencional

Inscrição (Estimado)

492

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria:

  1. Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.
  2. Participants must have documented disease progression or intolerance after at least 1 but not exceeding 2 prior lines of systemic therapy containing Programmed Cell Death Protein 1 / Programmed Death-Ligand 1 (PD-1/PD-L1). Prior cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) targeting therapy or v ascular endothelial growth factor (VEGF) is permitted but not required.
  3. Glypican-3 (GPC3) expression level must be known for stratification.
  4. Participants must have at least 1 measurable lesion as assessed by RECIST v1.1
  5. Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.

Key Exclusion Criteria:

  1. Prior therapy targeting GPC3 or 4-1BB

  2. Participants not feasible to be treated with lenvatinib or sorafenib

    1. prior exposure to both medications
    2. siginificant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose, tumor thombus involving main portal vein trunk, inferior vena cava, or cardiac involvement,
    3. any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,
    4. or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug.

  3. Active leptomeningeal disease or uncontrolled and untreated brain metastasis

  4. History of previous or present encephalopathy

  5. Presence of clinically significant ascites ((≥ Grade 2).

  6. History of liver transplantation

NOTE: Other eligbility criteria may apply.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BGB-B2033

Participants are randomized to receive BGB-B2033 until disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study, whichever occurs first.
Medicamento: BGB-B2033

Administered intravenously
Comparador Ativo: Investigator's choice: Lenvatinib OR sorafenib

Participants are randomized to receive either lenvatinib or sorafenib, selected by the investigator before treatment, until disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study, whichever occurs first.
Medicamento: Lenvatinib

Administered by mouth as an oral capsule once daily

Outros nomes:
  • Lenvima
Medicamento: Sorafenib

Administered by mouth as an oral tablet twice daily

Outros nomes:
  • Nexavar

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS)
Prazo: Up to approximately 3.5 years

OS is defined as the time from randomization to the date of death from any cause.
Up to approximately 3.5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Response Rate (ORR)
Prazo: Up to approximately 3.5 years

Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment and Blinded Independent Central Review (BICR) with confirmation per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to approximately 3.5 years
Duration of Response (DOR)
Prazo: Up to approximately 3.5 years

DOR is defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Assessed by BIRC and investigator with confirmation per RECIST v1.1.
Up to approximately 3.5 years
Progression Free Survival Rate (PFS)
Prazo: Up to approximately 3.5 years

PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment and BIRC with confirmation per RECIST v1.1
Up to approximately 3.5 years
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (imAEs)
Prazo: From first dose until either 30 days after the last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first (Up to approximately 3.5 years)

Safety will be assessed by monitoring and recording of all adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v6.0.
From first dose until either 30 days after the last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first (Up to approximately 3.5 years)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module [EORTC QLQ-HCC18]) Fatigue Scores
Prazo: From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT. Each cycle is 21 days.

The EORTC QLQ-HCC18 measures health related quality of life outcomes in participants with liver cancer. The 18-item questionnaire is conceptualized as consisting of 6 symptom domains, 2 single items and an Index score: fatigue (3 items), body image (2 items), jaundice (2 items), nutrition (5 items), pain (2 items), fever (2 items), abdominal swelling (1 item), and sex life (1 item). The Index score is a composite of all 18 items. The items are scored using a verbal-descriptive scale rated from 1 to 4 (1 = "not at all"; 4 = "very much"). Higher scores indicate worse symptoms.
From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT. Each cycle is 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Function 17 (EORTC QLQ-F17) Global Health Status (GHS), and Physical/Role Functioning scores
Prazo: From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT.

The EORTC QLQ-F17 is a generic core questionnaire that assesses self-reported functioning and GHS in participants with cancer. The EORTC QLQ-F17 includes predefined key participant reported outcomes (PRO) endpoints to measure GHS and physical functioning and role functioning. The functional items are scored on a 4-point verbal-descriptive scale (1 = "not at all"; 4 = "very much"), while the 2 GHS items use a 7-point scale (1 = "very poor"; 7 = "excellent"). Higher scores in GHS and functioning scales indicate better health related quality outcomes.
From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT.
Time to Deterioration of Fatigue Measured by EORTC QLQ-HCC18
Prazo: From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable (Up to approximately 3.5 years)

Time to deterioration in fatigue, as measured by the fatigue domain of the EORTC QLQ-HCC18 questionnaire. The fatigue domain consists of 3 items scored from 1 ("not at all") to 4 ("very much"). Higher scores indicate worse fatigue. Time to deterioration is defined as the time from randomization to the first clinically meaningful worsening in the fatigue score from baseline, based on the prespecified scoring criteria.
From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable (Up to approximately 3.5 years)
Time to Deterioration of Global Health Status and Physical/Role Functioning Measured by EORTC QLQ-F17.
Prazo: From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable ((Up to approximately 3.5 years).

Time to deterioration in global health status, physical functioning, and role functioning, as measured by the EORTC QLQ-F17 questionnaire. The questionnaire assesses participants' self-reported overall health, physical functioning, and ability to perform daily activities and roles. Higher scores indicate better health-related quality of life. Time to deterioration is defined as the time from randomization to the first clinically meaningful worsening from baseline in global health status, physical functioning, or role functioning, based on prespecified scoring criteria.
From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable ((Up to approximately 3.5 years).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

BeOne Medicines

Investigadores

  • Diretor de estudo: Study Director, BeOne Medicines

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

21 de setembro de 2029

Conclusão do estudo (Estimado)

21 de junho de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

17 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de setembro de 2026

Primeira postagem (Real)

23 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BGB-B2033-301
  • 2026-526462-25-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

See plan description

Critérios de acesso de compartilhamento IPD

See plan description

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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