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A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

3 de agosto de 2026 atualizado por: Boehringer Ingelheim

A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.

Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.

Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Fase 1

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

Locais de estudo

  • Espanha
      • Barcelona, Espanha, 08035
        • Recrutamento
        • Hospital Universitari Vall d'Hebron
        • Contato:
      • Pamplona, Espanha, 31008
        • Recrutamento
        • Clínica Universidad de Navarra
        • Contato:
      • Valencia, Espanha, 46010
        • Recrutamento
        • Hospital Clínico Universitario de Valencia
        • Contato:
  • Estados Unidos
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Ainda não está recrutando
        • Hackensack University Medical Center
        • Contato:
    • New York
      • New York, New York, Estados Unidos, 10016
        • Ainda não está recrutando
        • New York University Langone Medical Center
        • Contato:
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
  • Japão
      • Chiba, Kashiwa, Japão, 277-8577
        • Recrutamento
        • National Cancer Center Hospital East
        • Contato:
      • Tokyo, Chuo-ku, Japão, 104-0045
        • Recrutamento
        • National Cancer Center Hospital
        • Contato:

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria :

  1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.
  2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

  3. Patients with brain metastases are eligible provided they meet the following criteria:

    • Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,
    • Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
    • Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.
  4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor
  5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible [like hypothyroidism], and amenorrhea/menstrual disorders which can be any grade)
  6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion Criteria :

  1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:

    • Effectively treated non-melanoma skin cancers
    • Effectively treated carcinoma in situ of the cervix
    • Effectively treated ductal carcinoma in situ of the breast
    • Other effectively treated malignancy that is considered cured by local treatment
  2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
  3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment

  4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)
    • Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed
  5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
  6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
  7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)

  8. Patients with history of HIV infection who meet one or more of the following criteria:

    • CD4+ count <350 cells/µL
    • Viral load >400 copies/mL
    • Not receiving antiretroviral therapy
    • Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment
    • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria 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: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 1
Dose escalation
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 2
Dose escalation
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 3
Dose escalation
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 4
Dose escalation
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 5
Dose escalation
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill
Medicamento: BI 3819026
BI 3819026
Medicamento: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Prazo: Up to 30 days
Up to 30 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Occurrence of adverse events (AEs) with onset during the on-treatment period
Prazo: Up to 2 years
Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Prazo: Up to 2 years
Up to 2 years
Occurrence of AEs with onset during Cycle 1
Prazo: Up to 15 days
Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Prazo: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Prazo: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Prazo: Up to Day 30
Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Prazo: Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1
Prazo: Up to 15 days
Up to 15 days
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
Prazo: Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
Prazo: Up to Day 30
Up to Day 30
Treatment-induced changes in target cells as compared with baseline
Prazo: At baseline and up to 2 years
Backfill cohorts only: only patients in whom sequential biopsies are technically feasible and deemed safe by the investigator will be eligible
At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
Prazo: At baseline and up to 2 years
Backfill cohorts only
At baseline and up to 2 years

Colaboradores e Investigadores

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

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

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 (Real)

1 de maio de 2026

Conclusão Primária (Estimado)

5 de junho de 2028

Conclusão do estudo (Estimado)

15 de outubro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2012-0001
  • 2025-522953-21-00 (Identificador de registro: CTIS)
  • U1111-1328-0914 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Prazo de Compartilhamento de IPD

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Critérios de acesso de compartilhamento IPD

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

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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