Идёт набор NCT07319871

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of 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: Pasritamig, JNJ-86974680.
Кому может быть актуально: Состояния в реестре: Prostatic Neoplasms. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Великобритания
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 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer

Обзор

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.

Вмешательства

Препарат Pasritamig
Pasritamig will be administered intravenously.
Препарат JNJ-86974680
JNJ-86974680 will be administered orally.

Первичные конечные точки

Number of Participants With Adverse Events (AEs) by Severity [Срок оценки: Up to 1 year 2 months]
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) [Срок оценки: Up To Day 22]

Вторичные конечные точки (8)

Objective Response Rate (ORR) [Срок оценки: Up to 1 year 2 months]
Prostate-Specific Antigen (PSA) Response Rate [Срок оценки: Up to 1 year 2 months]
Duration of Response (DOR) [Срок оценки: Up to 1 year 2 months]
Radiographic Progression-Free Survival (rPFS) [Срок оценки: Up to 1 year 2 months]
Time to Response (TTR) [Срок оценки: Up to 1 year 2 months]
Serum Concentration of Pasritamig [Срок оценки: Up to 1 year 2 months]
Plasma Concentration of JNJ-86974680 [Срок оценки: Up to 1 year 2 months]
Number of Participants With Anti-Pasritamig Antibodies [Срок оценки: Up to 1 year 2 months]

Критерии участия

Критерии включения

Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \[e.g.\], immunohistochemistry \[IHC\] with both androgen receptor \[AR\]- and NE-marker positivity) are allowed
Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included
Prior orchiectomy or medical castration (for example, 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)
Prostate-specific antigen (PSA) greater than or equal to (>=) 2 nanograms per milliliters (ng/mL) at screening
Measurable or evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Критерии исключения

Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (<=) 1 or baseline levels (except for alopecia, neuropathy \[Grade 2\] and vitiligo)
Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680
Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Antibiotic or antiviral prophylaxis is allowed
Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic >2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment
Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

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

Здоровые добровольцы: Нет