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

Официальное название

A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Обзор

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.

Вмешательства

• Препарат HRS-5041 Single dose of HRS-5041 orally administered
  HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.

Первичные конечные точки

• Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination [Срок оценки: Screening up to study completion, an average of 1 year.]

Вторичные конечные точки (12)

• Concentration [Срок оценки: Screening up to study completion,an average of 1 year.]
• Cmax,ss [Срок оценки: From administration to C2, up to 4 months.]
• Cmin,ss [Срок оценки: From administration to C2, up to 4 months.]
• Objective Response Rate (ORR) [Срок оценки: Screening up to study completion, an average of 2 years.]
• Best of Response (DoR) [Срок оценки: Screening up to study completion, an average of 2 years.]
• Disease Control Rate (DCR) [Срок оценки: Screening up to study completion, an average of 2 years.]
• rPFS (radiographic progression-free survival [Срок оценки: Screening up to study completion, an average of 2 years.]
• PSA Response Rate at the end of Week 12 [Срок оценки: Screening up to the end of Week 12 , up to 4 months.]
• Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline) [Срок оценки: Screening up to the end of treatment, an average of 1 year.]
• Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline) [Срок оценки: Screening up to the end of treatment, an average of 1 year.]
• Time to PSA Progression [Срок оценки: From the date of first drug administration to the date of first PSA progression, an average of 1 year.]
• Overall Survival (OS) [Срок оценки: From the date of first drug administration to the date of death from any cause, an average of 2 year.]

Критерии участия

IInclusion Criteria

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
• Adequate bone marrow and other vital organ functions
• Adequate liver function tests
• Metastatic Castration-resistant Prostate Cancer

Критерии исключения

• Plan to receive any other anti-tumor therapy during the study.
• Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
• Uncontrolled hypertension (systolic blood pressure \[SBP\] > 150 mmHg and/or diastolic blood pressure \[DBP\] > 100 mmHg with regular anti-hypertension therapy).
• 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.
• Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
• Active heart disease within 6 months prior to the first dosing of this study.
• Medical history of other malignant tumor within 5 years prior to dosing.
• Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 11 центров

• GenesisCare North Shore (Oncology) — Sydney
• Sydney Adventist Hospital — Sydney
• Cancer Research SA — Adelaide
• Southern Oncology Clinical Research Unit — Adelaide
• Icon Cancer Centre South Brisbane — Brisbane
• John Flynn Private Hospital — Brisbane
• Eastern Health (Box Hill Hospital) — Melbourne
• Linear Clinical Research Ltd — Perth
• … и ещё 3 центра

Идентификаторы

NCT: NCT06830850 · HRS-5041-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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