NCT06783829招募中1 期
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-85 years old, male;
- •ECOG score for physical condition is 0-1 points;
- •Expected survival period ≥ 6 months;
- •Prostate adenocarcinoma confirmed by histological or cytological examination;
- •Patients with at least one metastasis lesion;
- •Disease progression on or after the most-recent prior regimen;
- •Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
- •Testosterone was at castration level;
- •Adequate organ function.
排除标准
- •Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
- •Unresolved to CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy;
- •Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- •Uncontrollable tumor-related pain;
- •Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
- •Other serious concomitant disease;
- •Previous or co-existing malignancies;
- •History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
- •Active hepatitis B or active hepatitis C;
- •Other inappropriate situation considered by the investigator.
研究组 & 干预措施
SHR4394
Experimental
干预措施: SHR4394 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 3 weeks.
Maximal tolerable dose (MTD)
时间窗: 3 weeks.
Adverse events (AEs)
时间窗: Screening up to study completion, an average of 1 year.
Recommended phase II dose (RP2D)
时间窗: Screening up to study completion, an average of 1 year.
次要结局
- Objective response rate (ORR)(Up to approximately 2 years.)
- Duration of response (DOR)(Up to approximately 2 years.)
- Disease control rate (DCR)(Up to approximately 2 years.)
- overall survival (OS)(Up to approximately 2 years.)
研究者
研究点 (1)
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