A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
28 de agosto de 2026 actualizado por: GlaxoSmithKline
A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)
This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better.
The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
684
Fase
- Fase 3
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
- Nombre: US GSK Clinical Trials Call Center
- Número de teléfono: 877-379-3718
- Correo electrónico: GSKClinicalSupportHD@gsk.com
Copia de seguridad de contactos de estudio
- Nombre: EU GSK Clinical Trials Call Center
- Número de teléfono: +44 (0) 20 89904466
- Correo electrónico: GSKClinicalSupportHD@gsk.com
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:
- Participants ≥18 years of age
- Has histologically or cytologically confirmed adenocarcinoma of the prostate.
- Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization.
- Has a life expectancy of at least 4 months.
- Has adequate organ function
Exclusion Criteria:
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
- Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix] with no evidence of metastatic disease.
- Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization,
- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV)
- Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
- Has received systemic immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term administration [30 days or longer]).
- Has received any prior therapy with an ADC with a topoisomerase 1 inhibitor (TOPO1-inhibitor) payload
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Risvutatug rezetecan (Ris-Rez)
Participants will receive Risvutatug rezetecan (Ris-Rez).
|
Risvutatug rezetecan (Ris-Rez) will be administered.
|
|
Comparador activo: Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
|
Se administrará abiraterona.
Se administrará enzalutamida.
Prednisone will be administered along with Abiraterone.
Prednisolone will be administered along with Abiraterone.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
Periodo de tiempo: Up to approximately 169 weeks
|
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
|
Up to approximately 169 weeks
|
|
Overall Survival (OS)
Periodo de tiempo: Up to approximately 169 weeks
|
OS is defined as the time from randomization to date of death by any cause.
|
Up to approximately 169 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Pain Progression (TTPP)
Periodo de tiempo: Up to approximately 169 weeks
|
Up to approximately 169 weeks
|
|
|
rPFS by Investigator assessment
Periodo de tiempo: Up to approximately 169 weeks
|
rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.
|
Up to approximately 169 weeks
|
|
Confirmed Objective Response Rate (cORR)
Periodo de tiempo: Up to approximately 169 weeks
|
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
|
Up to approximately 169 weeks
|
|
Duration of Response (DoR)
Periodo de tiempo: Up to approximately 169 weeks
|
DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.
|
Up to approximately 169 weeks
|
|
Time to Prostate-specific antigen (PSA) progression
Periodo de tiempo: Up to approximately 169 weeks
|
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
|
Up to approximately 169 weeks
|
|
Prostate-specific antigen 50 (PSA50) response
Periodo de tiempo: Up to approximately 169 weeks
|
PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.
|
Up to approximately 169 weeks
|
|
Time to first Symptomatic Skeletal-Related Event (SSRE)
Periodo de tiempo: Up to approximately 169 weeks
|
Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events:
|
Up to approximately 169 weeks
|
|
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Periodo de tiempo: Up to approximately 169 weeks
|
Up to approximately 169 weeks
|
|
|
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Periodo de tiempo: Up to approximately 169 weeks
|
Up to approximately 169 weeks
|
|
|
Serum concentration of Ris-Rez (conjugated antibody and payload)
Periodo de tiempo: Up to approximately 84 days
|
Up to approximately 84 days
|
|
|
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Periodo de tiempo: Up to approximately 169 weeks
|
Up to approximately 169 weeks
|
|
|
Titers of ADA against Ris-Rez
Periodo de tiempo: Up to approximately 169 weeks
|
Up to approximately 169 weeks
|
|
|
Participant-reported experience on study treatment
Periodo de tiempo: Up to approximately 169 weeks
|
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
|
Up to approximately 169 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
22 de septiembre de 2026
Finalización primaria (Estimado)
19 de diciembre de 2029
Finalización del estudio (Estimado)
19 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
28 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
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
28 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Neoplasias prostáticas
- Compuestos policíclicos
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esparrazadienetrioles
- Madreadiediols
- Prednisona
- Prednisolona
- abiraterona
- enzalutamida
Otros números de identificación del estudio
- 300145
- 2026-525558-13-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Marco de tiempo para compartir IPD
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Criterios de acceso compartido de IPD
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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.
No
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. .