QLC5508 in Participants With Metastatic Prostate Cancer
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial Comparing QLC5508 Versus Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Progressed After Treatment With Novel Hormonal Agents (NHA).
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Zhang Lei, B.M.
- 电话号码:0086-10-88196391
- 邮箱:zlei090903@163.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male, aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small-cell features.
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC).
- Prior treatment with novel hormonal agents (NHAs) and documented disease progression.
- Adequate organ function.
- Recovery from all reversible adverse events (AEs) related to prior anticancer therapies.
Exclusion Criteria:
1. Prior treatment with a B7-H3-targeted therapy, or with an antibody-drug conjugate (ADC) using a topoisomerase I inhibitor (TOP1i) as the payload, or with any TOP1i-class agent.
2. History of or current significant cardiovascular or cerebrovascular disease. 3. Active, uncontrolled infection. 4. Concurrent or prior history of another primary malignancy 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis, or current ILD/non-infectious pneumonitis 6. Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh class B or worse.
7. Known hypersensitivity or allergy to any investigational product or its excipients.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:QLC5508 arm
|
2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
|
|
有源比较器:Docetaxel arm
|
75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Radiographic Progression Free Survival (rPFS)
大体时间:Up to approximately 36 months
|
Up to approximately 36 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
客观缓解率 (ORR)
大体时间:最长约 36 个月
|
最长约 36 个月
|
|
总生存期 (OS)
大体时间:最长约 36 个月
|
最长约 36 个月
|
|
Prostate-specific Antigen (PSA) Response Rate
大体时间:Up to approximately 36 months
|
Up to approximately 36 months
|
|
Time to Prostate-specific Antigen (PSA) Progression
大体时间:Up to approximately 36 months
|
Up to approximately 36 months
|
|
Time to Pain Progression (TTPP)
大体时间:Up to approximately 36 months
|
Up to approximately 36 months
|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
大体时间:Up to approximately 36 months
|
Up to approximately 36 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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