NCT07230106招募中2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Cohort 1 Group
Experimental
干预措施: HS-20093 for Injection (Drug)
Cohort 1 Group
Experimental
干预措施: SHR3680 Tablet (Drug)
Cohort 1 Group
Experimental
干预措施: Abiraterone Tablet (Drug)
Cohort 2 Group
Experimental
干预措施: SHR3680 Tablet (Drug)
Cohort 2 Group
Experimental
干预措施: SHR2554 Tablet (Drug)
Cohort 2 Group
Experimental
干预措施: Enzalutamide Tablet (Drug)
Cohort 2 Group
Experimental
干预措施: Darotamine Capsule (Drug)
结局指标
主要结局
Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.
时间窗: 6 months.
Cohort 2: Prostate Specific Antigen (PSA) response rate.
时间窗: About 2 years.
Cohort 2: Adverse events (AEs).
时间窗: About 2 years.
Cohort 2: Dose-limiting toxicity (DLT).
时间窗: About 28 days.
次要结局
- Time to Prostate Specific Antigen (PSA) progression.(About 2 years.)
- Objective response rate (ORR).(About 2 years.)
- Cohort 1: Adverse events (AEs).(About 2 years.)
- Radiographic Progression-Free Survival (rPFS).(About 2 years.)
- Time to Next Symptomatic Skeletal Event (SSE).(About 2 years.)
- Duration of response (DoR).(About 2 years.)
- Time to Next Antineoplastic Therapy (TTNT).(About 2 years.)
- Disease control rate (DCR).(About 2 years.)
- Overall Survival (OS).(About 2 years.)
研究者
研究点 (2)
Loading locations...
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