Seguridad y eficacia de las terapias para el cáncer de próstata metastásico resistente a la castración (mCRPC)
4 de agosto de 2026 actualizado por: Amgen
Un protocolo maestro que evalúa la seguridad y la eficacia de las terapias para el cáncer de próstata metastásico resistente a la castración (mCRPC)
Este es un protocolo maestro diseñado para evaluar la seguridad y la eficacia de las terapias en investigación en participantes con cáncer de próstata metastásico resistente a la castración (mCRPC).
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Este es un protocolo maestro diseñado para evaluar la seguridad, la tolerabilidad y la dosis máxima tolerada (MTD) o la dosis de fase 2 recomendada (RP2D) y la eficacia de Acapatamab, en combinación con enzalutamida, abiraterona o el inhibidor de PD1 AMG 404, AMG 404 en monoterapia. , así como la monoterapia con acapatamab, en pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm).
Tipo de estudio
Intervencionista
Inscripción (Actual)
55
Fase
- Fase 2
- 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.
Ubicaciones de estudio
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- St Vincents Hospital Sydney
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København Ø, Dinamarca, 2100
- Rigshospitalet
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Navarre
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Pamplona, Navarre, España, 31008
- Clinica Universidad de Navarra
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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California
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Orange, California, Estados Unidos, 92868
- University of California at Irvine Medical Center
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San Francisco, California, Estados Unidos, 94158
- University of California San Francisco Mission Bay Campus
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University Of Chicago
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Sutton, Reino Unido, SM2 5PT
- Royal Marsden Hospital
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Lund, Suecia, 221 85
- Skånes universitetssjukhus
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Stockholm, Suecia, 171 76
- Karolinska Universitetssjukhuset Solna
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Uppsala, Suecia, 75185
- Akademiska sjukhuset
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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 a 99 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Todas las partes
Criterios de inclusión:
- ≥ 18 años de edad (o la mayoría de edad legal dentro del país)
- El sujeto ha dado su consentimiento informado antes del inicio de cualquier actividad/procedimiento específico del estudio.
- Sujetos con CPRCm con adenocarcinoma de próstata confirmado histológica o citológicamente
- Los sujetos deben haberse sometido a una orquiectomía bilateral o deben estar en terapia continua de privación de andrógenos con un agonista o antagonista de la hormona liberadora de gonadotropina (testosterona ≤ 50 ng/dL (o 1,7 nmol/L))
Criterio de exclusión:
- Metástasis del sistema nervioso central (SNC) o enfermedad leptomeníngea
- Antecedentes o presencia de patología del SNC clínicamente relevante
- Antecedentes confirmados o enfermedad autoinmune actual u otras enfermedades que requieren terapia inmunosupresora permanente
- Infarto de miocardio, hipertensión no controlada, angina inestable, arritmia cardíaca que requiere medicación y/o insuficiencia cardíaca congestiva sintomática (New York Heart Association > clase II) dentro de los 12 meses
- Tratamiento previo con un taxano para mCRPC
- Cirugía mayor y/o radiación dentro de las 4 semanas
Antecedentes o evidencia de infección por coronavirus 2 del síndrome respiratorio agudo severo (SARS-CoV-2), a menos que se acuerde con un monitor médico y cumpla con los siguientes criterios:
- Prueba negativa de ARN del SARS-CoV-2 por reacción en cadena de la polimerasa en tiempo real (RT-PCR) dentro de las 72 horas posteriores a la primera dosis de Acapatamab (o AMG 404 en la Parte 3)
- Sin síntomas agudos de la enfermedad COVID-19 dentro de los 10 días anteriores a la primera dosis de Acapatamab (o AMG 404 en la Parte 3) (contados desde el día de la prueba positiva para sujetos asintomáticos)
Experiencia previa/concurrente en estudios clínicos
- Recibe actualmente tratamiento en otro dispositivo de investigación o estudio de medicamentos, o hace menos de 4 semanas desde que finalizó el tratamiento en otro dispositivo de investigación o estudio de medicamentos. Se excluyen otros procedimientos de investigación durante la participación en este estudio, con la excepción de las exploraciones de investigación.
Subprotocolo A solamente:
Criterios de inclusión
• Sujetos que planean recibir enzalutamida por primera vez para mCRPC
Criterio de exclusión
- Uso de inhibidores potentes de CYP2C8 o inductores potentes de CYP3A4
- Uso de fármacos de índice terapéutico estrecho que son sustratos de CYP3A4, CYP2C9 o CYP2C19
Solo subprotocolo B:
Criterios de inclusión
- Sujetos que planean recibir abiraterona por primera vez para mCRPC Criterios de exclusión
- Insuficiencia hepática moderada y grave basal (Child-Pugh Clase B y C)
- Presencia de hipertensión no controlada, hipopotasemia o retención de líquidos
- Historia o presencia de insuficiencia adrenocortical
- Uso de medicamentos concomitantes que son sustratos sensibles para CYP2D6 con un índice terapéutico estrecho
- Uso de inductores potentes de CYP3A4
Solo subprotocolo C:
Criterios de inclusión
- Sujetos que son refractarios a una nueva terapia antiandrogénica. Los sujetos no deben ser elegibles para la terapia con taxanos o rechazarla.
- Evidencia de enfermedad progresiva, definida como 1 o más criterios PCWG3: nivel de PSA >/= 1 ng/mL que ha aumentado en al menos 2 ocasiones sucesivas con al menos 1 semana de diferencia, progresión ganglionar o visceral según lo definido por RECIST 1.1 con modificaciones PCGW3, y/o aparición de 2 o más lesiones nuevas en gammagrafía ósea Criterios de exclusión
- Historia o evidencia de enfermedad pulmonar intersticial o neumonitis no infecciosa activa
- Sujetos con un inhibidor previo de PD-1 o PD-L1 que experimentaron un evento adverso relacionado con el sistema inmunitario de grado 3 o superior antes del primer día de la dosis
Solo subprotocolo D:
Criterios de inclusión
- Los sujetos pueden haber recibido terapias hormonales novedosas (NHT; por ejemplo, abiraterona, enzalutamida, apalutamida o darolutamida) para el cáncer de próstata, pero no más de 1 NHT para el cáncer de próstata metastásico.
- No elegible para o rechazar la terapia con taxanos
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: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Acapatamab y enzalutamida: exploración de dosis
La parte de exploración de dosis del estudio estimará la MTD/dosis de fase 2 recomendada (RP2D) de acapatamab en combinación con enzalutamida.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
La enzalutamida se administrará por vía oral.
Otros nombres:
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Experimental: Acapatamab y enzalutamida: expansión de dosis
Luego de la exploración de dosis, se llevará a cabo una expansión de dosis para confirmar la seguridad y tolerabilidad de la dosis seleccionada y para evaluar más a fondo la eficacia de acapatamab en combinación con enzalutamida.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
La enzalutamida se administrará por vía oral.
Otros nombres:
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Experimental: Acapatamab y abiraterona: exploración de dosis
La parte de exploración de dosis del estudio estimará la MTD/dosis de fase 2 recomendada (RP2D) de acapatamab en combinación con abiraterona.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
La abiraterona se administrará por vía oral.
Otros nombres:
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Experimental: Acapatamab y abiraterona: expansión de dosis
Luego de la exploración de dosis, se llevará a cabo una expansión de dosis para confirmar la seguridad y tolerabilidad de la dosis seleccionada y para evaluar más a fondo la eficacia de acapatamab en combinación con abiraterona.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
La abiraterona se administrará por vía oral.
Otros nombres:
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Experimental: Acapatamab y AMG 404: Exploración de dosis
La parte de exploración de dosis del estudio estimará la MTD/RP2D de Acapatamab en combinación con AMG 404.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
AMG 404 se administrará como infusión intravenosa (IV).
Otros nombres:
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Experimental: Acapatamab y AMG 404: Expansión de dosis
Luego de la exploración de dosis, se realizará una expansión de dosis para confirmar la seguridad y tolerabilidad de la dosis seleccionada y para evaluar más a fondo la eficacia de Acapatamab en combinación con AMG 404.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
AMG 404 se administrará como infusión intravenosa (IV).
Otros nombres:
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Comparador activo: AMG 404 Monoterapia
La monoterapia con AMG 404 se está realizando para evaluar la actividad antitumoral preliminar de la inhibición de PD-1 en la población de mCRPC.
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AMG 404 se administrará como infusión intravenosa (IV).
Otros nombres:
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Experimental: Acapatamab y enzalutamida: expansión de dosis Cohorte de Asia
Después de la exploración de dosis, la expansión de la dosis se llevará a cabo en la cohorte de Asia en la combinación MTD/RP2D determinada en la exploración de dosis para confirmar la seguridad, tolerabilidad y farmacocinética de acapatamab en combinación con enzalutamida para sujetos en Asia.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
La enzalutamida se administrará por vía oral.
Otros nombres:
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Experimental: Acapatamab y abiraterona: expansión de dosis Cohorte de Asia
Después de la exploración de dosis, la expansión de la dosis se llevará a cabo en la cohorte de Asia en la combinación MTD/RP2D determinada en la exploración de dosis para confirmar la seguridad, tolerabilidad y farmacocinética de acapatamab en combinación con abiraterona para sujetos en Asia.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
La abiraterona se administrará por vía oral.
Otros nombres:
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Experimental: Acapatamab y AMG 404: Cohorte asiática de expansión de dosis
Después de la exploración de dosis, la expansión de la dosis se llevará a cabo en la cohorte de Asia en la combinación MTD/RP2D determinada en la exploración de dosis para confirmar la seguridad, tolerabilidad y PK de Acapatamab en combinación con AMG 404 para sujetos en Asia.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
AMG 404 se administrará como infusión intravenosa (IV).
Otros nombres:
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Experimental: Monoterapia con acapatamab
La monoterapia con acapatamab se está realizando para evaluar la seguridad, la tolerabilidad, la farmacocinética (PK), la farmacodinámica y la eficacia de acapatamab en sujetos con CPRCm.
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Acapatamab se administrará como una infusión intravenosa (IV).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Periodo de tiempo: Cycle 1: Day 1 to Day 28 (28-day cycle)
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DLTs were defined as any adverse event (AE) (per Common Terminology Criteria for Adverse Events (CTCAE) v5: Grade 5=Death, Grade 4=Life-threatening, Grade 3=Moderate) occurring within 28 days of the first AMG 160 dose, possibly related to the treatment, including:
The complete list of DLTs are described in the protocol |
Cycle 1: Day 1 to Day 28 (28-day cycle)
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs
Periodo de tiempo: From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
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A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started on or after first dose of investigational product (AMG 160 or AMG 404 for Part 1 and 2; AMG 404 for Part 3). A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab, or AMG 404 (subprotocol C, parts 1 and 2 only). Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
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Subprotocol D: Number of Participants Who Experienced TEAEs and Treatment-related AEs
Periodo de tiempo: From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
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A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab. A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab. Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
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Subprotocol C, Part 3: Objective Response Rate (ORR)
Periodo de tiempo: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
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Objective Response is defined as a complete response (CR) or partial response (PR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later.
Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
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From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a Circulating Tumor Cell 0 (CTC0) Response
Periodo de tiempo: Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement).
The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
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Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a CTC Conversion Response
Periodo de tiempo: Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement.
The baseline was defined as the last non-missing value on or prior to the pre-dose assessments of AMG 404 on Cycle 1 Day 1.
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Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a Prostate Specific Antigen (PSA) Response
Periodo de tiempo: Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1. |
Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Subprotocols A. B, C (Parts 1 and 2) and D: ORR
Periodo de tiempo: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Objective Response is defined as a CR or PR per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later.
Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
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From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC0 Response
Periodo de tiempo: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement).
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1 > 0.
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From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC Conversion Response
Periodo de tiempo: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement.
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
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From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a PSA Response
Periodo de tiempo: Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1. |
Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC0 Response
Periodo de tiempo: From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Duration of CTC0 response was defined as the time from the date of initial CTC0 response to the earlier of CTC0 progression or death.
Participants who had not ended their response at the time of analysis had duration of CTC0 response censored on the date of their last CTC0 or CTC conversion assessment.
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From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC Conversion Response
Periodo de tiempo: From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Duration of CTC conversion response was defined as the time from the date of an initial CTC conversion response to the earlier of CTC conversion progression or death.
Participants who had not ended their response at the time of analysis had duration of CTC response censored on the date of their last CTC0 or CTC conversion assessment.
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From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of PSA Response
Periodo de tiempo: From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Duration of PSA response was defined as the time of an initial PSA response (PSA 50) to the earlier of PSA progression or death.
Participants who had not ended their response at the time of analysis had duration of PSA response censored on the date of their last PSA measurement.
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From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of Response Per RECIST 1.1
Periodo de tiempo: From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Duration of response per RECIST 1.1 was defined as the time from the date of an initial objective response (CR/PR) per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death.
CR/PR must have been confirmed at least 4 weeks later.
Participants who had not ended their response at the time of analysis had duration of response censored at their last evaluable tumor assessment by computed tomography (CT)/magnetic resonance imaging (MRI) scan.
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From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Overall Survival (OS)
Periodo de tiempo: From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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OS was defined as the time from the date of trial Day 1 until death due to any cause.
OS time (months) = (date of death - trial Day 1 + 1) x 12/365.25.
Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was alive.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Kalbfleisch and Prentice.
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From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Radiographic Progression Free Survival (rPFS)
Periodo de tiempo: From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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rPFS was defined as the time from trial Day 1 to radiographic progression.
If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without disease progression (PD) or death recorded, rPFS was censored on the date of the first dose of the investigational product (IP).
rPFS was censored at the last evaluable radiographic tumor assessment date for participants who had no PD, death or new anti-cancer therapy reported, started a new anti-cancer therapy prior to PD or death, if death recorded without new anti-cancer therapy and without PD, if death or PD immediately after more than one consecutively missed tumor assessment occurred.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
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From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: PSA PFS
Periodo de tiempo: From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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PSA PFS was defined as the interval from trial Day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement.
If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or known, PSA PFS was censored at trial Day 1.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
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From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Clinical PFS
Periodo de tiempo: From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Clinical PFS was defined as the time from the first dose to clinical disease progression or death from any cause.
If a participant had no evaluable post-baseline or on-trial disease assessment or was on trial without PD or death recorded, clinical PFS was censored on the date of the first dose of the IP.
Otherwise, clinical PFS was censored on the date of last assessment.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
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From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Radiographic Progression
Periodo de tiempo: From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to radiographic progression was defined as the interval from Day 1 to radiographic progression in the absence of subsequent anticancer therapy. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without PD or death recorded, time to radiographic progression was censored on the date of the first dose of the IP. Time to radiographic progression was censored on the date of last evaluable radiographic tumor assessment for participants who:
The median was estimated using the Kaplan-Meier method and the 95% CI was estimated using the method by Brookmeyer and Crowley. |
From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to PSA Progression
Periodo de tiempo: From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to PSA progression was defined as the interval from trial Day 1 to PSA progression.
If a participant had no evaluable post-baseline or on-trial PSA assessment, time to PSA progression was censored on the date of the first dose of the IP.
Otherwise, time to PSA progression was censored on the date of the last PSA assessment.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
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From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Subsequent Therapy
Periodo de tiempo: From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to subsequent therapy was defined as the interval from trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy; otherwise, time to subsequent therapy was censored at the last known date of any of the trial assessments prior to initiating the subsequent cancer therapy/subsequent therapy.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Percentage of Participants Who Experienced a Gallium Prostate-specific Membrane Antigen-11 (PSMA-11) Response
Periodo de tiempo: Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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A Gallium PSMA-11 response was defined as a ≥ 50% reduction from baseline in the maximum standardized update value (SUV) using 68Gallium (68Ga)-PSMA-11 positron emission tomography (PET)/CT.
PSMA-11 response percentages were based on the number of participants with a baseline PSMA assessment (defined as the last non-missing value on or prior to the pre-dose of acapatamab/AMG 404 assessments) on Cycle 1 Day 1.
The 95% confidence interval was calculated based on the Clopper-Pearson method.
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Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Symptomatic Skeletal Events
Periodo de tiempo: From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Time to symptomatic skeletal events was defined as time from trial Day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of acapatamab/AMG 404 or end of safety follow-up date, whichever was later.
Symptomatic skeletal events included fracture, spinal cord compression and radiation or surgery to bone.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Total Alkaline Phosphatase Levels
Periodo de tiempo: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Alkaline phosphatase levels were collected locally and centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Bone Specific Alkaline Phosphatase Levels
Periodo de tiempo: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Bone specific alkaline phosphatase levels were collected locally and centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Lactate Dehydrogenase Levels
Periodo de tiempo: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Lactate dehydrogenase levels were collected locally and centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Hemoglobin Levels
Periodo de tiempo: Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Hemoglobin levels were collected locally.
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Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Neutrophil-to-lymphocyte Ratio
Periodo de tiempo: Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Data for the neutrophil-to-lymphocyte ratio were collected locally.
Neutrophil-to-lymphocyte ratio was calculated by dividing the number of absolute neutrophils by the number of lymphocytes.
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Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Urine N-telopeptide Levels
Periodo de tiempo: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Urine N-telopeptide levels were collected centrally.
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Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
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Subprotocol A, B and C (Parts 1 and 2) and D: Maximum Serum Concentration (Cmax) of Acapatamab
Periodo de tiempo: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol A, B and C (Parts 1 and 2) and D: Area Under the Curve Over the Dosing Interval (AUCtau)
Periodo de tiempo: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol A, B and C (Parts 1 and 2) and D: Time to Reach Cmax (Tmax) of Acapatamab
Periodo de tiempo: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol A, B and C (Parts 1 and 2) and D: Terminal Half-life (t1/2z) of Acapatamab
Periodo de tiempo: Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
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Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol C, Part 3: Number of Participants Who Experienced TEAEs and Treatment-related AEs
Periodo de tiempo: From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks
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A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab. A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab. Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: MD, Amgen
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)
15 de enero de 2021
Finalización primaria (Actual)
23 de octubre de 2023
Finalización del estudio (Actual)
23 de octubre de 2023
Fechas de registro del estudio
Enviado por primera vez
13 de noviembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
13 de noviembre de 2020
Publicado por primera vez (Actual)
17 de noviembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
- CPRCm
- Acapatamab
- MORDIDA DE VIDA MEDIA EXTENDIDA (HLE)
- Cáncer de próstata metastásico resistente a la castración
- 68
- Membrana específica de próstata de galio (68Ga)
- antígeno (PSMA)-11 emisión de positrones
- tomografía (PET)/tomografía computarizada (TC)
- y
- 18
- F-fluorodesoxiglucosa (FDG) PET/TC
- evaluación de respuesta basada
- Engager biespecífico de células T
- MORDER
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Trastornos inducidos químicamente
- Envenenamiento
- Mordeduras y Picaduras
- Agentes antineoplásicos inmunológicos
- Agentes antineoplásicos
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica.
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Antagonistas hormonales
- Antagonistas de andrógenos
- Aminoácidos, péptidos y proteínas
- Proteínas
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Enzimas
- Enzimas y coenzimas
- Oxidorreductasas
- Citocromos
- Oxigenasas de función mixta
- Oxigenasas
- Hemeproteínas
- Inhibidores de puntos de control inmunitarios
- Antagonistas del receptor de andrógenos
- abiraterona
- enzalutamida
- Sistema enzimático citocromo P-450
Otros números de identificación del estudio
- 20190505
- 2020-001305-23 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Datos de pacientes individuales desidentificados para las variables necesarias para abordar la pregunta de investigación específica en una solicitud de intercambio de datos aprobada.
Marco de tiempo para compartir IPD
Las solicitudes de intercambio de datos relacionadas con este estudio se considerarán a partir de los 18 meses posteriores a la finalización del estudio y 1) el producto y la indicación han obtenido la autorización de comercialización tanto en los EE. UU. como en Europa o 2) el desarrollo clínico del producto y/o la indicación se interrumpe y los datos no se enviarán a las autoridades reguladoras.
No hay una fecha límite para la elegibilidad para enviar una solicitud de intercambio de datos para este estudio.
Criterios de acceso compartido de IPD
Los investigadores calificados pueden enviar una solicitud que contenga los objetivos de la investigación, los productos de Amgen y el alcance de los estudios de Amgen, los criterios de valoración/resultados de interés, el plan de análisis estadístico, los requisitos de datos, el plan de publicación y las calificaciones de los investigadores.
En general, Amgen no concede solicitudes externas de datos de pacientes individuales con el fin de reevaluar los problemas de seguridad y eficacia ya abordados en la etiqueta del producto.
Las solicitudes son revisadas por un comité de asesores internos.
Si no se aprueba, un Panel de Revisión Independiente de Intercambio de Datos arbitrará y tomará la decisión final.
Tras la aprobación, la información necesaria para abordar la pregunta de investigación se proporcionará bajo los términos de un acuerdo de intercambio de datos.
Esto puede incluir datos de pacientes individuales anonimizados y/o documentos de respaldo disponibles, que contengan fragmentos de código de análisis donde se proporcione en las especificaciones de análisis.
Más detalles están disponibles en la siguiente URL.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- 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. .