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Набор скоро начнётся NCT07746713

A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer

Фаза I С лечением Prostatic Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: JNJ-98768111.
Кому может быть актуально
Состояния в реестре: Prostatic Neoplasms. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer

Обзор

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).

Вмешательства

  • Препарат JNJ-98768111
    JNJ-98768111 will be administered intravenously.

Первичные конечные точки

  • Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 2 years 7 months]
  • Part 1: Number of Participants with Dose-Limiting Toxicities (DLT) [Срок оценки: From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)]
Вторичные конечные точки (10)
  • Maximum Observed Concentration (Cmax) of JNJ-98768111 [Срок оценки: Up to approximately 2 years 7 months]
  • Trough Concentration (Ctrough) of JNJ-98768111 [Срок оценки: Up to approximately 2 years 7 months]
  • Time to Maximum Observed Concentration (Tmax) of JNJ-98768111 [Срок оценки: 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 [Срок оценки: Up to approximately 2 years 7 months]
  • Accumulation Ratio of JNJ-98768111 [Срок оценки: Up to approximately 2 years 7 months]
  • Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111 [Срок оценки: Up to approximately 2 years 7 months]
  • Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years 7 months]
  • Radiographic Progression-Free Survival (rPFS) [Срок оценки: Up to approximately 2 years 7 months]
  • Prostate-Specific Antigen (PSA) Response [Срок оценки: Up to approximately 2 years 7 months]
  • Duration of Response (DOR) [Срок оценки: Up to approximately 2 years 7 months]

Критерии участия

Критерии включения

  • 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
  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07746713 · 98768111PCR1001 · 2026-525894-37-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗