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Набира участници Фаза 1/2 NCT07332455

First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Neoplasms, Prostate

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a monotherapy in mCRPC.
Кой може да участва
Inclusion Criteria: * Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Progression on ADT and \>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens. Exclusion Criteria: * Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma. * Impaired cardiac function or clinically significant cardiac disease. * Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality. * Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.
Интервенции
GSK5471713
DRUG
Места на провеждане 6
Канада (2)
GSK Investigational Site
Montreal , Quebec
US GSK Clinical Trials Call Center
GSK Investigational Site
Toronto , Ontario
US GSK Clinical Trials Call Center
Япония (1)
GSK Investigational Site
Tokyo
US GSK Clinical Trials Call Center
САЩ (3)
GSK Investigational Site
Grand Rapids , Michigan
US GSK Clinical Trials Call Center
GSK Investigational Site
Philadelphia , Pennsylvania
US GSK Clinical Trials Call Center
GSK Investigational Site
West Valley City , Utah
US GSK Clinical Trials Call Center
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.02.2026
Крайна дата
26.03.2030
Регистрационен номер
NCT07332455
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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