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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

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

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.

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

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. .

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