A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
详细描述
This Phase II clinical trial aims to evaluate the efficacy and safety of Enhertu in HER-2 positive mCRPC who have progressed on prior androgen deprivation therapy and novel hormonal agents, who are either not candidates for or have refused taxane based chemotherapy. Led by Dr. Maneesh Jain at the Washington DC VA, the open label multi center study will include 60 participants treated with Enhertu. Primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed adenocarcinoma of the prostate
- •Diagnosis of mCRPC
- •Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen
- •Ongoing ADT to maintain serum testosterone levels below 50 ng/dL
- •Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry
- •Life expectancy 6 months
- •ECOG 0 or 1
- •LVEF at least 50%
- •Adequate Blood Clotting function
- •Adequate Organ and Bone Marrow function
- •Adequate Renal function
- •Adequate Hepatic function
排除标准
- •History of interstitial lung disease or pneumonitis requiring steroids
- •Significant coronary vascular disease
- •Previous exposure to HER2 targeted therapy
研究组 & 干预措施
Enhertu for HER2 positive metastatic castrate resistant prostate cancer
干预措施: Enhertu (Drug)
结局指标
主要结局
ORR
时间窗: 2 years
Objective Response Rate by local review, combining radiographic and biochemical responses
次要结局
- Progression Free Survival(2 years)
- Overall Survival(2 years)
- Disease Control Rate(2 years)
- Duration of Response(2 years)