- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07746713
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
27 de agosto de 2026 actualizado por: Janssen Research & Development, LLC
A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer
The purpose of Part 1 of this study is to find out how safe JNJ-98768111 is and the most suitable dose (recommended phase 2 dose [RP2D]) regimen(s) of JNJ-98768111.
The purpose of Part 2 of this study is to find out how safe JNJ-98768111 is at the RP2D regimen(s) in participants with advanced prostate cancer (cancer of the prostate, a male reproductive gland found below the bladder, which has spread extensively to other parts of the body).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- 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.
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
-
-
Florida
-
Sarasota, Florida, Estados Unidos, 34232
- Reclutamiento
- Florida Cancer Specialists & Research Institute
-
-
Michigan
-
Grand Rapids, Michigan, Estados Unidos, 49546
- Reclutamiento
- START MidWest
-
-
Utah
-
West Valley City, Utah, Estados Unidos, 84119
- Reclutamiento
- START Mountain Region
-
-
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:
- a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy. c. Serum prostate-specific antigen (PSA) value greater than or equal to (>=) 2 nanograms per milliliters (ng/mL). d. Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of trial drug and must continue this therapy throughout the treatment phase; e. Castrate levels of serum testosterone as defined in the protocol, prior to the first dose of trial intervention; f. Progressive metastatic disease following their most recent line of therapy. Disease progression will be defined by at least one of the following: PSA progression, radiographic progression according to response evaluation criteria in solid tumors (RECIST v1.1), or progressive bone disease according to prostate cancer working group 3 (PCWG3) criteria
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Agree to all of the following during the trial and for 6 months after the last dose of trial drug: a. Use a highly effective method of contraception; b. Wear a condom when engaging in any activity that allows for passage of ejaculate to another person; c. Not to donate sperm or freeze for future use for the purpose of reproduction; d. Not plan to father a child. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception
- Sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the trial and is willing to participate in the trial
Exclusion criteria:
- Active central nervous system (CNS) involvement
- Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels
- External beam radiation therapy to soft tissue lesions within 14 days prior to start of trial intervention
- History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
- History of solid organ or bone marrow transplantation
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: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: JNJ-98768111
Participants in Part 1 of the study will receive escalating doses of JNJ-98768111 to identify the putative recommended phase 2 dose (pRP2D) regimen(s).
Participants in Part 2 of the study will receive JNJ-98768111 at the pRP2D regimen(s) determined in Part 1.
|
JNJ-98768111 will be administered intravenously.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Up to approximately 2 years 7 months
|
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
|
Up to approximately 2 years 7 months
|
|
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
Periodo de tiempo: From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)
|
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
Other DLT criteria includes any related toxicity resulting in permanent treatment discontinuation or a delay in dose administration greater than (>)14 days and any death not clearly due to the underlying disease or non-trial intervention-related causes.
|
From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Observed Concentration (Cmax) of JNJ-98768111
Periodo de tiempo: Up to approximately 2 years 7 months
|
Cmax of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Trough Concentration (Ctrough) of JNJ-98768111
Periodo de tiempo: Up to approximately 2 years 7 months
|
Ctrough of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
Periodo de tiempo: Up to approximately 2 years 7 months
|
Tmax of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Area Under the Concentration-Time Curve from Time 0 to End of Dosing Interval (AUC [0-tau]) of JNJ-98768111
Periodo de tiempo: Up to approximately 2 years 7 months
|
AUC0-tau of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Accumulation Ratio of JNJ-98768111
Periodo de tiempo: Up to approximately 2 years 7 months
|
Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.
|
Up to approximately 2 years 7 months
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111
Periodo de tiempo: Up to approximately 2 years 7 months
|
Number of participants with antibodies to JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Objective Response Rate (ORR)
Periodo de tiempo: Up to approximately 2 years 7 months
|
ORR is defined as the percentage of participants with measurable disease who have a partial response (PR) or better without evidence of bone progression according to prostate cancer working group 3 (PCWG3).
|
Up to approximately 2 years 7 months
|
|
Radiographic Progression-Free Survival (rPFS)
Periodo de tiempo: Up to approximately 2 years 7 months
|
rPFS is defined as the time from the date of first dose until the date of objective disease progression or death, whichever comes first.
|
Up to approximately 2 years 7 months
|
|
Prostate-Specific Antigen (PSA) Response
Periodo de tiempo: Up to approximately 2 years 7 months
|
PSA response rate is defined as the percentage of participants with a decline in PSA of 50% or more from baseline which is sustained for greater than or equal to (>=) 3 weeks.
|
Up to approximately 2 years 7 months
|
|
Duration of Response (DOR)
Periodo de tiempo: Up to approximately 2 years 7 months
|
DOR will be calculated among responders (PR or better) from the date of initial documentation of a 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 approximately 2 years 7 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development LLC Clinical Trial, Janssen Research & Development, LLC
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)
5 de agosto de 2026
Finalización primaria (Estimado)
16 de marzo de 2029
Finalización del estudio (Estimado)
16 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
5 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 98768111PCR1001
- 2026-525894-37-00 (Identificador de registro: EUCT number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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.
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. .