Un estudio para probar diferentes dosis de BI 1831169 solo y en combinación con ezabenlimab en personas con diferentes tipos de cáncer avanzado (tumores sólidos)
Ensayo de fase I abierto, de aumento de dosis de BI 1831169 en monoterapia y en combinación con ezabenlimab en pacientes con tumores sólidos avanzados o metastásicos
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.
This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.
Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Tübingen, Alemania, 72076
- Universitätsklinikum Tübingen
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Ulm, Alemania, 89081
- Universitätsklinikum Ulm
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South Australia
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Bedford Park, South Australia, Australia, 5062
- Southern Oncology Clinical Research Unit
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Victoria
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Frankston, Victoria, Australia, 3199
- Peninsula Haematology & Oncology
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Innsbruck, Austria, 6020
- Medical University of Innsbruck
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Salzburg, Austria, 5020
- Salzburg Cancer Research Institute
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Edegem, Bélgica, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Bélgica, 3000
- UZ Leuven
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Princess Margaret Cancer Centre
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L'Hospitalet de Llobregat, España, 08907
- Hospital Duran i Reynals
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Madrid, España, 28040
- Fundación Jiménez Díaz
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Pamplona, España, 31008
- Clínica Universidad de Navarra
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Arizona
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Gilbert, Arizona, Estados Unidos, 85234
- Banner MD Anderson Cancer Center-Gilbert-55251
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Tucson, Arizona, Estados Unidos, 85719
- University of Arizona
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California
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La Jolla, California, Estados Unidos, 92037
- University of California San Diego
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Santa Monica, California, Estados Unidos, 90404
- Providence St. John's Health Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Denver
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami
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Orlando, Florida, Estados Unidos, 32806
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- M Health Fairview University of Minnesota Medical Center
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Morristown Medical Center
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- Prisma Health
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
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Bordeaux, Francia, 33000
- INS Bergonie
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Marseille, Francia, 13385
- HOP Timone
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Rennes, Francia, 35042
- CTR Eugène Marquis
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Villejuif, Francia, 94805
- Institut Gustave Roussy
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Milan, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Geneva, Suiza, 1205
- University Hospital Geneva
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
- At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
- Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.
Further inclusion criteria apply.
Exclusion Criteria:
- Previous treatment with Vesicular stomatitis virus (VSV)-based agents
- Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
- Presence of brain metastases
- Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
- Chronic steroid use, regardless of daily dose Further exclusion criteria apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Parte 1 (Monoterapia): Grupo A
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BI 1831169 |
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Experimental: Parte 1 (Monoterapia): Grupo B
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BI 1831169 |
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Experimental: Parte 1 (Monoterapia): Grupo C
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BI 1831169 |
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Experimental: Parte 2 (terapia combinada): grupo D
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BI 1831169 anti-PD-1 antibody |
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Experimental: Parte 2 (terapia combinada): grupo E
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BI 1831169 anti-PD-1 antibody |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
Periodo de tiempo: up to 21 days
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Part 1 (Monotherapy). |
up to 21 days
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Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
Periodo de tiempo: up to 49 months
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BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. |
up to 49 months
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Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
Periodo de tiempo: up to 21 days
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Part 2 (Combination Therapy). |
up to 21 days
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Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)
Periodo de tiempo: up to 49 months
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BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment. BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first). |
up to 49 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Parte 1.1, Aumento de dosis/Confirmación: aparición de DLT durante el período de tratamiento
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Parte 1.1, Aumento de dosis/Confirmación: aparición de eventos adversos durante el período de tratamiento
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Parte 1.2, Ampliación de dosis: aparición de eventos adversos durante el período de tratamiento
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Parte 1.2, Ampliación de dosis: aparición de DLT durante el período de evaluación mono MTD
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Parte 2.1, Aumento de dosis/Confirmación: aparición de DLT durante el período de tratamiento
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Parte 2.1, Aumento de dosis/Confirmación: aparición de eventos adversos durante el período de tratamiento
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Parte 2.2 - Ampliación de dosis por indicación, todas las ramas: aparición de eventos adversos durante el período de tratamiento
Periodo de tiempo: hasta 49 meses
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hasta 49 meses
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Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
Periodo de tiempo: up to 49 months
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DoR is defined as the time from first documented iCR or iPR according to iRECIST until the earliest of disease progression by Investigator's assessment or death among patients with OR. |
up to 49 months
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Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)
Periodo de tiempo: up to 49 months
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DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment. |
up to 49 months
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Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)
Periodo de tiempo: up to 4 months
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PFS-4 is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment. PFS is assessed by the Investigator using iRECIST. |
up to 4 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1456-0001
- 2020-003902-30 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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