Un ensayo de fase III de BNT324 frente a docetaxel en cáncer de próstata metastásico resistente a la castración
Un ensayo de fase III, aleatorizado y de etiqueta abierta de BNT324 frente a docetaxel con prednisona/prednisolona en el cáncer de próstata resistente a la castración metastásico
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.
The main goals of this study are:
- To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival [rPFS]).
- To find out if BNT324 helps participants live longer overall (overall survival [OS]).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period.
Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review [BICR] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends.
Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results.
For each participant, the treatment and follow-up periods are projected to be up to ~58 months.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: BioNTech clinical trials patient information
- Número de teléfono: +49 6131 9084
- Correo electrónico: patients@biontech.de
Ubicaciones de estudio
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Dresden, Alemania, 1307
- Reclutamiento
- Universitätsklinikum Carl Gustav Carus
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Hamburg, Alemania, 22763
- Reclutamiento
- Asklepios Klinik Altona
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Southport, Australia, 4215
- Reclutamiento
- Tasman Onco Research Pty Ltd
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Brussels, Bélgica, 1200
- Reclutamiento
- Cliniques Universitaires Saint-Luc
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California
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Santa Barbara, California, Estados Unidos, 93105
- Reclutamiento
- Sansum Clinic
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Colorado
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Aurora, Colorado, Estados Unidos, 80012
- Reclutamiento
- Rocky Mountain Cancer Centers
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Florida
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Fort Myers, Florida, Estados Unidos, 33901
- Reclutamiento
- Florida Cancer Specialists- Fort Myers
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St. Petersburg, Florida, Estados Unidos, 33701
- Reclutamiento
- Florida Cancer Specialists- St. Petersburg
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West Palm Beach, Florida, Estados Unidos, 33401
- Reclutamiento
- Florida Cancer Specialists- West Palm Beach
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Georgia
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Atlanta, Georgia, Estados Unidos, 30318
- Reclutamiento
- Piedmont Cancer Institute
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Illinois
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Niles, Illinois, Estados Unidos, 60714
- Reclutamiento
- Illinois Cancer Specialists
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Peoria, Illinois, Estados Unidos, 61615
- Reclutamiento
- Illinois CancerCare PC
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Maryland
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Rockville, Maryland, Estados Unidos, 20850
- Reclutamiento
- Maryland Oncology Hematology
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New York
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Albany, New York, Estados Unidos, 12206
- Reclutamiento
- NYOH Albany Cancer Center
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White Plains, New York, Estados Unidos, 10601
- Reclutamiento
- White Plains Hospital
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Reclutamiento
- Oncology/Hematology Care, Inc.
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South Carolina
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Myrtle Beach, South Carolina, Estados Unidos, 29572
- Reclutamiento
- START Carolinas
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Tennessee Oncology
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- SCRI Oncology Partners
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Texas
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Austin, Texas, Estados Unidos, 78731
- Reclutamiento
- Texas Oncology South Austin
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Houston, Texas, Estados Unidos, 77024
- Reclutamiento
- Texas Oncology Gulf Coast
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Tyler, Texas, Estados Unidos, 75702
- Reclutamiento
- Texas Oncology, P.A. - Tyler
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Wichita Falls, Texas, Estados Unidos, 76310
- Reclutamiento
- Texas Oncology - West Texas
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Reclutamiento
- Virginia Cancer Specialists PC
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Norfolk, Virginia, Estados Unidos, 23502
- Reclutamiento
- Virginia Oncology Associates
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Krakow, Polonia, 30-727
- Reclutamiento
- Pratia MCM Krakow
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Warsaw, Polonia, 02-781
- Reclutamiento
- National Research Institute of Oncology - National Research Institute (NIO-PIB)
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Beijing, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital
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Beijing, Porcelana, 100034
- Reclutamiento
- Peking University First Hospital
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Changsha, Porcelana, 410005
- Reclutamiento
- The First Affiliated Hospital of Hunan Normal University
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Chengdu, Porcelana, 610041
- Reclutamiento
- West China Hospital, Sichuan University
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Chongqing, Porcelana, 400072
- Reclutamiento
- The Second Affiliated Hospital of Chongqing Medical University
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Fuzhou, Porcelana, 350001
- Reclutamiento
- Fujian Medical University Union Hospital
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Hangzhou, Porcelana, 310022
- Reclutamiento
- Zhejiang Cancer Hospital
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Hangzhou, Porcelana, 310016
- Reclutamiento
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hefei, Porcelana, 230601
- Reclutamiento
- Second Hospital of Anhui Medical University
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Nanchang, Porcelana, 330006
- Reclutamiento
- The First Affiliated Hospital of Nanchang University
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Nanjing, Porcelana, 210008
- Reclutamiento
- Nanjing Drum Tower Hospital
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Shanghai, Porcelana, 200032
- Reclutamiento
- Shanghai Cancer Center
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Shanghai, Porcelana, 200072
- Reclutamiento
- No. 10 People's Hospital of Shanghai
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Wenzhou, Porcelana, 325000
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Porcelana, 430079
- Reclutamiento
- Hubei Cancer Hospital
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Wuhan, Porcelana, 420104
- Reclutamiento
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhu, Porcelana, 241001
- Reclutamiento
- Yijishan Hospital of Wannan Medical College
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Yantai, Porcelana, 264000
- Reclutamiento
- Yantai Yuhuangding Hospital
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Cambridge, Reino Unido, CB2 0QQ
- Reclutamiento
- Addenbrooke's Hospital
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Cardiff, Reino Unido, CF14 2TL
- Reclutamiento
- Velindre Cancer Centre
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Leeds, Reino Unido, LS9 7TF
- Reclutamiento
- St James's University Hospital
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London, Reino Unido, SW3 6JJ
- Reclutamiento
- Royal Marsden Hospital
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Reclutamiento
- Freeman Hospital
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Southampton, Reino Unido, SO16 6YD
- Reclutamiento
- Southampton General Hospital
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Sutton, Reino Unido, SM2 5PT
- Reclutamiento
- Royal Marsden Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
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Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
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Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
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Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
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Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
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Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.
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Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.
Key Exclusion Criteria:
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Plan de estudios
¿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 |
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Experimental: BNT324
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Intravenous infusion
Otros nombres:
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Comparador activo: Docetaxel más prednisona/prednisolona
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Intravenous infusion Oral |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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rPFS assessed by BICR
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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OS
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. OS is defined as time from randomization to death from any cause. |
From randomization to end of study, i.e., up to 58 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to first subsequent therapy (TFTS)
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Objective response rate (ORR)
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response. |
From randomization to end of study, i.e., up to 58 months
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Duration of response (DOR)
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Time to pain progression (TTPP)
Periodo de tiempo: From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
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By arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 "worst pain in 24 hours" and opiate analgesic use (Analgesic Quantification Algorithm score). |
From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
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rPFS as assessed by investigator
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
|
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Time to first symptomatic skeletal-related event (SSRE)
Periodo de tiempo: From randomization to end of study, i.e., up to 58 months
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By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs:
|
From randomization to end of study, i.e., up to 58 months
|
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Time to prostate-specific antigen (PSA) progression (by central lab testing results)
Periodo de tiempo: From baseline to end of treatment visit, i.e., up to 58 months
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By arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
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PSA response (by central lab testing results)
Periodo de tiempo: From baseline to end of treatment visit, i.e., up to 58 months
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By arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
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Number and percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs
Periodo de tiempo: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
TEAEs by relationship and by arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
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Number and percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
Periodo de tiempo: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
By arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: BioNTech Responsible Person, BioNTech SE
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BNT324-03
- 2025-524445-27-00 (Ctis)
- 2025 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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