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Набира участници Фаза 1 NCT06830850

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

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

Спонсор: Atridia Pty Ltd.

Налично на: БГ
Обобщение
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Кой може да участва
IInclusion Criteria 1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. Adequate bone marrow and other vital organ functions 3. Adequate liver function tests 4. Metastatic Castration-resistant Prostate Cancer Exclusion Criteria 1. Plan to receive any other anti-tumor therapy during the study. 2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study. 3. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 mmHg and/or diastolic blood pressure \[DBP\] \> 100 mmHg with regular anti-hypertension therapy). 4. Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP. 5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.). 6. Active heart disease within 6 months prior to the first dosing of this study. 7. Medical history of other malignant tumor within 5 years prior to dosing. 8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
Места на провеждане 1
Австралия (1)
GenesisCare North Shore (Oncology)
Sydney , New South Wales
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.06.2025
Крайна дата
15.03.2027
Регистрационен номер
NCT06830850
Източник
anzctr
Запитване за медицински туризъм

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