Идёт набор NCT07082920

A Study of JNJ-78278343 in Combination With JNJ-95298177 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: JNJ-78278343, JNJ-95298177.
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: США, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer

Обзор

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.

Вмешательства

Препарат JNJ-78278343
JNJ-78278343 will be administered intravenously.
Препарат JNJ-95298177
JNJ-95298177 will be administered intravenously.

Первичные конечные точки

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

Вторичные конечные точки (9)

Objective Response Rate (ORR) [Срок оценки: Up to 2 years 2 months]
Prostate-Specific Antigen (PSA) Response Rate [Срок оценки: Up to 2 years 2 months]
Radiographic Progression-Free Survival (rPFS) [Срок оценки: Up to 2 years 2 months]
Time to Response (TTR) [Срок оценки: Up to 2 years 2 months]
Duration of Response (DOR) [Срок оценки: Up to 2 years 2 months]
Serum Concentration of JNJ-78278343 [Срок оценки: Up to 2 years 2 months]
Serum Concentration of JNJ-95298177 [Срок оценки: Up to 2 years 2 months]
Number of Participants With Anti-JNJ-78278343 Antibodies [Срок оценки: Up to 2 years 2 months]
Number of Participants With Anti-JNJ-95298177 Antibodies [Срок оценки: Up to 2 years 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
Must have metastatic castration-resistant prostate cancer (mCRPC)
PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening
Measurable or evaluable disease
Prior orchiectomy or medical castration; or, for 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
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 and vitiligo)
Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343 or JNJ-95298177
Participants with leptomeningeal disease or brain metastases, with the exception of participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic greater than (>) 2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment
Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment; specific requirements for certain anti-cancer therapies are as follows:

Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell \[CAR-T\] therapy) within 90 days prior to the first dose of study treatment
Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment
Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment
Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy
Any prior prostate-specific membrane antigen (PSMA)-targeting therapy (that is \[i.e.\], participants who received PSMA-targeting radioconjugates are excluded) \[Parts 2A and 2B only\]. Prior PSMA RLT is allowed in Part 1 and required for Part 2C and Part 2D but last dose must be >3 months prior to the first dose of study treatment
Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins)
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