A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer

Официальное название

A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer

Обзор

This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.

Вмешательства

• Препарат HS-20093 for Injection
  HS-20093 for injection.
• Препарат SHR3680 Tablet
  SHR3680 tablet.
• Препарат Abiraterone Tablet
  Abiraterone tablet.
• Препарат SHR2554 Tablet
  SHR2554 tablet.
• Препарат Enzalutamide Tablet
  Enzalutamide tablet.
• Препарат Darotamine Capsule
  Darotamine capsule.

Первичные конечные точки

• Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate. [Срок оценки: 6 months.]
• Cohort 2: Prostate Specific Antigen (PSA) response rate. [Срок оценки: About 2 years.]
• Cohort 2: Adverse events (AEs). [Срок оценки: About 2 years.]
• Cohort 2: Dose-limiting toxicity (DLT). [Срок оценки: About 28 days.]

Вторичные конечные точки (9)

• Radiographic Progression-Free Survival (rPFS). [Срок оценки: About 2 years.]
• Time to Prostate Specific Antigen (PSA) progression. [Срок оценки: About 2 years.]
• Time to Next Symptomatic Skeletal Event (SSE). [Срок оценки: About 2 years.]
• Time to Next Antineoplastic Therapy (TTNT). [Срок оценки: About 2 years.]
• Objective response rate (ORR). [Срок оценки: About 2 years.]
• Cohort 1: Adverse events (AEs). [Срок оценки: About 2 years.]
• Disease control rate (DCR). [Срок оценки: About 2 years.]
• Duration of response (DoR). [Срок оценки: About 2 years.]
• Overall Survival (OS). [Срок оценки: About 2 years.]

Критерии участия

Критерии включения

• Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.
• Aged 18 to 80 years (inclusive), male.
• ECOG performance status of 0 or 1.
• Expected survival time ≥12 weeks.
• Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
• Able to provide sufficient tumor tissue samples for retrospective genetic testing.
• Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
• PSA level ≥1 ng/ml at screening.
• Adequate organ function levels at baseline assessment.
• Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.

Критерии исключения

• Known hypersensitivity or intolerance to the investigational drug(s) or their excipients.
• Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.
• Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.
• Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.
• Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment.
• Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months.
• Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease.
• Poorly controlled tumor-related pain.
• Dysphagia or other conditions significantly affecting drug absorption.
• Known central nervous system metastases or primary brain tumors.
• Significant pericardial, pleural, or peritoneal effusion requiring intervention.
• Severe cardiovascular or cerebrovascular diseases.
• Moderate to severe pulmonary disease significantly affecting respiratory function.
• Poorly controlled diabetes.
• Serious active infections within 14 days prior to enrollment.
• Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases.
• History of other malignancies within 5 years prior to enrollment.
• Any other condition deemed by the investigator to potentially affect the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Nanjing Drum Tower Hospital — Нанкин
• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07230106 · SHR3680-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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