Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • España
      • Barcelona, España, 08035
        • Reclutamiento
        • Hospital Universitari Vall d'Hebron
        • Contacto:
      • Pamplona, España, 31008
        • Reclutamiento
        • Clinica Universidad de Navarra
        • Contacto:
      • Valencia, España, 46010
        • Reclutamiento
        • Hospital Clínico Universitario de Valencia
        • Contacto:
  • Estados Unidos
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Aún no reclutando
        • Hackensack University Medical Center
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10016
        • Aún no reclutando
        • New York University Langone Medical Center
        • Contacto:
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Reclutamiento
        • SCRI Oncology Partners
        • Contacto:
  • Japón
      • Chiba, Kashiwa, Japón, 277-8577
        • Reclutamiento
        • National Cancer Center Hospital East
        • Contacto:
      • Tokyo, Chuo-ku, Japón, 104-0045
        • Reclutamiento
        • National Cancer Center Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 1
Dose escalation
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 2
Dose escalation
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 3
Dose escalation
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 4
Dose escalation
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 5
Dose escalation
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill
Droga: BI 3819026
BI 3819026
Droga: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Occurrence of adverse events (AEs) with onset during the on-treatment period
Periodo de tiempo: Up to 2 years
Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Periodo de tiempo: Up to 2 years
Up to 2 years
Occurrence of AEs with onset during Cycle 1
Periodo de tiempo: Up to 15 days
Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Periodo de tiempo: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Periodo de tiempo: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Periodo de tiempo: Up to Day 30
Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to Day 30
Up to Day 30
Treatment-induced changes in target cells as compared with baseline
Periodo de tiempo: 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
Periodo de tiempo: At baseline and up to 2 years
Backfill cohorts only
At baseline and up to 2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2026

Finalización primaria (Estimado)

5 de junio de 2028

Finalización del estudio (Estimado)

15 de octubre de 2030

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

26 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir