Un estudio de JNJ-87189401 más JNJ-78278343 para el cáncer de próstata avanzado
Un estudio de fase 1 de JNJ-87189401 (anticuerpo biespecífico PSMA-CD28) combinado con JNJ-78278343 (anticuerpo biespecífico KLK2-CD3) para el cáncer de próstata avanzado
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Greenslopes, Australia, 4120
- Reclutamiento
- Greenslopes Private Hospital
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Melbourne, Australia, 3000
- Reclutamiento
- Peter MacCallum Cancer Centre
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- University of Colorado Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Reclutamiento
- Emory University Winship Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University Of Minnesota
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New Jersey
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East Brunswick, New Jersey, Estados Unidos, 08816
- Reclutamiento
- START New Jersey
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New York
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New York, New York, Estados Unidos, 10032
- Reclutamiento
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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The Bronx, New York, Estados Unidos, 10467
- Reclutamiento
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Reclutamiento
- Atrium Health Levine Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Reclutamiento
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Reclutamiento
- Sidney Kimmel Cancer Center - Jefferson Health
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Tennessee Oncology
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- South Texas Accelerated Research Therapeutics, LLC (START)
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Reclutamiento
- Swedish Medical Center
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Bordeaux, Francia, 33000
- Reclutamiento
- Institut Bergonie
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Lyon, Francia, 69008
- Reclutamiento
- Centre Leon Berard
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Villejuif, Francia, 94800
- Reclutamiento
- Institut Gustave Roussy
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Tokyo, Japón, 135 8550
- Reclutamiento
- The Cancer Institute Hospital of JFCR
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Chongqing, Porcelana, 400030
- Reclutamiento
- Chongqing University Cancer Hospital
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Wenzhou, Porcelana, 325000
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Porcelana, 710004
- Reclutamiento
- The First Affiliated Hospital of Xian Jiaotong University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
- Measurable or evaluable disease per PCWG3 criteria
- Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- History of an autoimmune disease within the 12 months prior to signing consent
- Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part 1 (Dose Escalation)
Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). |
JNJ-87189401 will be administered.
Otros nombres:
JNJ-78278343 will be administered.
Otros nombres:
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Experimental: Part 2 (Dose Expansion)
Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. |
JNJ-87189401 will be administered.
Otros nombres:
JNJ-78278343 will be administered.
Otros nombres:
Apalutamide will be administered. |
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Experimental: Part 3
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. |
JNJ-87189401 will be administered.
Otros nombres:
JNJ-78278343 will be administered.
Otros nombres:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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Experimental: Part 4
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. |
JNJ-87189401 will be administered.
Otros nombres:
JNJ-78278343 will be administered.
Otros nombres:
JNJ-101556143 will be administered.
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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Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Periodo de tiempo: Up to 21 days after first combination dose of study drugs
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DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. |
Up to 21 days after first combination dose of study drugs
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Number of Participants with Adverse Events (AEs) by Severity
Periodo de tiempo: Up to 4 years 8 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. |
Up to 4 years 8 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serum Concentrations of JNJ-87189401 and JNJ-78278343
Periodo de tiempo: Up to 4 years 8 months
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Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. |
Up to 4 years 8 months
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Plasma Concentration of JNJ-101556143
Periodo de tiempo: Up to 4 years 8 months
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Plasma samples will be analyzed to determine concentrations of JNJ-101556143. |
Up to 4 years 8 months
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Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Periodo de tiempo: Up to 4 years 8 months
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Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. |
Up to 4 years 8 months
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Objective Response Rate (ORR)
Periodo de tiempo: Up to 4 years 8 months
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ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3). |
Up to 4 years 8 months
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Radiographic Progression-Free Survival (rPFS)
Periodo de tiempo: Up to 4 years 8 months
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rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. |
Up to 4 years 8 months
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Prostate Specific Antigen (PSA) Response Rate
Periodo de tiempo: Up to 4 years 8 months
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PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. |
Up to 4 years 8 months
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Duration of Response (DOR)
Periodo de tiempo: Up to 4 years 8 months
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DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first. |
Up to 4 years 8 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR109330
- 87189401PCR1001 (Otro identificador: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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.
producto fabricado y exportado desde los EE. UU.
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. .