NCT07735377招募中1 期
A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-6914 Injection in Participants 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
- 118
- 试验地点
- 2
- 主要终点
- Incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- •Presence of metastatic lesions confirmed by evaluable imaging examinations (per PCWG4, evaluable imaging examinations refer to examinations with definite lesion assessment criteria, including CT, MRI or bone scan).
- •Has an ECOG PS 0-
- •Has a life expectancy of ≥ 3 months.
- •Has adequate organ function
排除标准
- •With untreated local therapy (radiotherapy or surgery) or active central nervous system (CNS) tumor metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis.
- •Patients with other malignant tumors within 5 years prior to the first study drug administration, excluding adequately treated basal cell carcinoma or squamous cell carcinoma.
- •Those with uncontrolled tumor-related pain as judged by the investigator, who require analgesic medication.
- •Having severe cardiovascular and cerebrovascular diseases
- •Suffering from active severe digestive system diseases
- •History of prior interstitial pneumonia
- •Has active infection requiring systemic treatment.
- •Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤1
研究组 & 干预措施
SHR-6914
Experimental
干预措施: SHR-6914 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT)
时间窗: six month
Incidence and severity of adverse events (AEs)
时间窗: six month
Serious adverse events (SAEs) .
时间窗: six month
MTD
时间窗: 1 year
RP2D
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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