Un estudio de ALX148 con cetuximab y pembrolizumab para el cáncer colorrectal metastásico estable microsatélite refractario
12 de agosto de 2026 actualizado por: University of Colorado, Denver
Un estudio de fase II (con prueba de seguridad) de ALX148 en combinación con cetuximab y pembrolizumab en pacientes con cáncer colorrectal metastásico estable microsatélite refractario
Este estudio clínico de fase 2 evaluará ALX148 en combinación con cetuximab y pembrolizumab para el cáncer colorrectal metastásico resistente a microsatélites estable
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Este es un ensayo clínico de fase II de etiqueta abierta, multicéntrico, de un solo brazo (con prueba de seguridad) que evalúa la combinación de ALX148, cetuximab y pembrolizumab en pacientes con cáncer colorrectal metastásico microsatélite estable que han progresado en al menos 2 líneas de terapia sistémica.
Un subconjunto de pacientes se someterá a biopsias relacionadas con el estudio.
Habrá una etapa de rodaje de seguridad seguida de una etapa de expansión de dosis.
Los pacientes en ambos estadios seguirán recibiendo la terapia del estudio hasta la progresión de la enfermedad según RECIST v1.1.
Tipo de estudio
Intervencionista
Inscripción (Actual)
19
Fase
- Fase 2
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.
Ubicaciones de estudio
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Arizona
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Tucson, Arizona, Estados Unidos, 85724
- University of Arizona Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Cancer Center
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08903
- Rutgers Cancer insititute
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Inova Schar Cancer Institute
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
Para ser elegible para participar en este estudio, una persona debe cumplir con todos los siguientes criterios:
- Tener un diagnóstico de cáncer colorrectal metastásico tratado previamente con al menos dos líneas de terapia para la enfermedad irresecable/metastásica
- Tiene enfermedad estable de microsatélites
- Función hematológica y de órganos diana adecuada
Criterio de exclusión:
Cualquier persona que cumpla con cualquiera de los siguientes criterios será excluida de la participación en este estudio:
- Pacientes con estado alto de MSI conocido o deficiencia conocida de reparación de desajustes (dMMR)
- Pacientes en los que se desconoce tanto la reparación del desajuste como el estado de estabilidad de los microsatélites
- Antecedentes de reacciones alérgicas, anafilácticas u otras reacciones de hipersensibilidad graves a cualquiera de los medicamentos del estudio o sus clases
- Cáncer colorrectal metastásico de tipo salvaje RAS/BRAF del lado izquierdo (en o distal a la flexión esplénica) que no han recibido inhibidores de EGFR.
- Terapia previa con un agente anti-PD-1, anti-PD-L1, anti-PD L2, anti-CD47 o anti-SIRPα o con un agente dirigido a otro receptor de células T estimulador o coinhibidor (p. ej., CTLA- 4, BUEY 40, CD137)
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 Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
Doses:
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IV QW
Otros nombres:
IV Q3W
Otros nombres:
IV QW
Otros nombres:
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Experimental: Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
Doses:
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IV QW
Otros nombres:
IV Q3W
Otros nombres:
IV QW
Otros nombres:
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Experimental: Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
Doses:
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IV QW
Otros nombres:
IV Q3W
Otros nombres:
IV QW
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response Rate (ORR)
Periodo de tiempo: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
|
A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
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The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
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Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab
Periodo de tiempo: During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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The recommended dose (RD) of evorpacept was determined by evaluating the totality of the first-cycle clinical data.
Rules to determine the RD based on the number of patients experiencing a dose-limiting toxicity (DLT) were defined in the protocol.
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During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration Of Response (DOR)
Periodo de tiempo: From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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DOR is defined as the length of time (months) from the 1st response (CR or PR per RECIST v1.1) until either the first observation of progressive disease (PD) or death from any cause.
Patients who did not experience PD or die are considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
This is a subgroup analysis, consisting of all patients who experienced response (CR or PR per RECIST v1.1)
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From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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Progression-Free Survival (PFS)
Periodo de tiempo: For each subject, from enrollment until the end of their months-to-progression (as defined above)
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Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
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For each subject, from enrollment until the end of their months-to-progression (as defined above)
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Overall Survival (OS)
Periodo de tiempo: For each subject, from enrollment until the end of their months-to-death time (as defined above)
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Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
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For each subject, from enrollment until the end of their months-to-death time (as defined above)
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Disease Control Rate (DCR)
Periodo de tiempo: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS - Response-Evaluable Population
Periodo de tiempo: For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
|
For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
|
OS - Response-Evaluable Population
Periodo de tiempo: For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
|
For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
|
ORR - Response-Evaluable Population
Periodo de tiempo: The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
|
The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
|
DCR - Response-Evaluable Population
Periodo de tiempo: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wells Messersmith, MD, University of Colorado, Denver
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.
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)
28 de julio de 2022
Finalización primaria (Actual)
30 de octubre de 2024
Finalización del estudio (Actual)
30 de octubre de 2024
Fechas de registro del estudio
Enviado por primera vez
27 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
9 de diciembre de 2021
Publicado por primera vez (Actual)
22 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades del Colon
- Neoplasias colorrectales
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Cetuximab
- pembrolizumab
- Alx148
Otros números de identificación del estudio
- 22-0110.cc
- AGICC-ALX148 21CRC01 (Otro identificador: AGICC)
- NCI-2022-02019 (Otro número de subvención/financiamiento: CTRP)
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. .