Um estudo investigando BGB-26808 sozinho ou em combinação com Tislelizumabe em participantes com tumores sólidos avançados
Um estudo de fase 1 investigando a segurança, tolerabilidade, farmacocinética e atividade antitumoral preliminar do inibidor de HPK1 BGB-26808 sozinho ou em combinação com o anticorpo monoclonal anti-PD-1 tislelizumabe em pacientes com tumores sólidos avançados
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Study Director
- Número de telefone: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Locais de estudo
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New South Wales
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Miranda, New South Wales, Austrália, NSW 2228
- Concluído
- Southside Cancer Care
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North Ryde, New South Wales, Austrália, NSW 2109
- Ativo, não recrutando
- Macquarie University
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South Australia
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Kurralta Park, South Australia, Austrália, SA 5037
- Ativo, não recrutando
- Icon Cancer Centre Kurralta Park
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Western Australia
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Nedlands, Western Australia, Austrália, WA 6009
- Concluído
- Linear Clinical Research
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Anhui
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Hefei, Anhui, China, 230022
- Recrutamento
- The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Recrutamento
- Harbin Medical University Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430079
- Recrutamento
- Hubei Cancer Hospital
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Wuhan, Hubei, China, 430101
- Recrutamento
- Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
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Liaoning
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Shenyang, Liaoning, China, 110167
- Recrutamento
- The First Hospital of China Medical University Hunnan Branch
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Shandong
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Jining, Shandong, China, 272000
- Recrutamento
- Jining No1 Peoples Hospital West Branch
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Yantai, Shandong, China, 264000
- Recrutamento
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200123
- Recrutamento
- Shanghai East Hospital Branch Hospital
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Shanghai, Shanghai Municipality, China, 200433
- Concluído
- Shanghai Pulmonary Hospital
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Sichuan
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Chengdu, Sichuan, China, 610071
- Recrutamento
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- Recrutamento
- Hangzhou First Peoples Hospital
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Taizhou, Zhejiang, China, 317004
- Concluído
- Taizhou Hospital of Zhejiang Province (East)
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California
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Duarte, California, Estados Unidos, 91010-3012
- Recrutamento
- City of Hope National Medical Center
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Los Angeles, California, Estados Unidos, 90033
- Recrutamento
- University of Southern California Norris Comprehensive
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Recrutamento
- Yale University Yale Cancer Center
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Florida
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Miami, Florida, Estados Unidos, 33136
- Recrutamento
- Sylvester Cancer Center, University of Miami
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-5316
- Recrutamento
- University of Michigan Health System
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Recrutamento
- John Theurer Cancer Center Hackensack University Medical Center
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New York
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New York, New York, Estados Unidos, 10029-6504
- Recrutamento
- Icahn School of Medicine At Mount Sinai
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Oregon
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Portland, Oregon, Estados Unidos, 97213-2933
- Concluído
- Providence Portland Medical Center
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Texas
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Houston, Texas, Estados Unidos, 77030-4009
- Recrutamento
- The University of Texas Md Anderson Cancer Center
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Auckland, Nova Zelândia, 1023
- Recrutamento
- Auckland City Hospital
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Auckland, Nova Zelândia, 1023
- Recrutamento
- Harbour Cancer and Wellness
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Rotorua, Nova Zelândia, 3010
- Recrutamento
- Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
- Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
- Adequate organ function.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for up to ≥ 270 days after the last dose of chemotherapy.
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.
Exclusion Criteria:
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment(s).
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
- Uncontrolled diabetes.
- Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Phase 1a: Dose Escalation
Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab. |
Planned doses administered orally as a tablet daily. Planned doses administered by intravenous infusion.
Outros nomes:
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Experimental: Phase 1b: Dose Expansion
Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated. |
Planned doses administered orally as a tablet daily. Planned doses administered by intravenous infusion.
Outros nomes:
Administered in accordance with relevant local guidelines and/or prescribing information. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
|
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria. |
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
Prazo: Approximately 1 month
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MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. |
Approximately 1 month
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Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
Prazo: Approximately 1 month
|
RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD. |
Approximately 1 month
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Phase 1b: Overall Response Rate (ORR)
Prazo: Approximately 6 months
|
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
Approximately 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Phase 1a and 1b: Plasma concentrations of BGB-26808
Prazo: Approximately 6 months
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Approximately 6 months
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Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
Prazo: Approximately 1 month
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Approximately 1 month
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Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
Prazo: Approximately 1 month
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Approximately 1 month
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Phase 1a: ORR
Prazo: Approximately 6 months
|
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1. |
Approximately 6 months
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Phase 1a and 1b: Duration of Response (DOR)
Prazo: Approximately 9 months
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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 as assessed by the investigator. |
Approximately 9 months
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Phase 1a and 1b: Disease Control Rate (DCR)
Prazo: Approximately 6 months
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DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator. |
Approximately 6 months
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Phase 1a and 1b: Clinical Benefit Rate (CBR)
Prazo: Approximately 6 months
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CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator. |
Approximately 6 months
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Phase 1b: Progression Free Survival (PFS)
Prazo: Approximately 9 months
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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 assessed by the investigator using RECIST v1.1 or death, whichever occurs first. |
Approximately 9 months
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Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
Prazo: Approximately 1 month
|
Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters. |
Approximately 1 month
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Phase 1b: Number of Participants with AEs and SAEs
Prazo: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
|
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria. |
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Study Director, BeOne Medicines
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BGB-A317-26808-101
- CTR20240210 (Outro identificador: ChinaDrugTrials)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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
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