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Набира участници Фаза 1 NCT07545811

Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Prostate Cancer Metastatic Castration-resistant Prostate Cancer Castration-resistant Prostate Cancer

Спонсор: Janux Therapeutics

Налично на: БГ
Обобщение
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Кой може да участва
Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible. * Adequate organ function * For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible. Exclusion Criteria: * Prior solid organ transplant * Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy * Clinically significant cardiovascular disease
Интервенции
JANX014
BIOLOGICAL
Места на провеждане 1
САЩ (1)
Research Site
Nashville , Tennessee
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.04.2026
Крайна дата
01.03.2029
Регистрационен номер
NCT07545811
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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