A Study of QLS5132 in Platinum-Resistant Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of QLS5132 Versus Investigator's Choice of Chemotherapy in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
The goal of this interventional study is to compare the effectiveness and safety of QLS5132 monotherapy with investigator's choice of chemotherapy in participants with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
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：Tao Zhu, Master
- 电话号码：13858065156
- 邮箱：zhutao@zjcc.org.cn
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Female participants aged ≥ 18 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Platinum-resistant recurrent disease, defined as disease progression within 6 months (≤183 days) after the last platinum-based chemotherapy.
- At least one measurable lesion per RECIST v1.1.
- ECOG performance status of 0 or 1.
- Expected survival ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Negative pregnancy test for women of childbearing potential, and agreement to use effective contraception.
Exclusion Criteria:
- Prior treatment with CLDN6-targeting therapy or topoisomerase I inhibitors (e.g., topotecan, trastuzumab deruxtecan).
- Active or untreated central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with stable, treated CNS metastases may be eligible).
- Clinically significant cardiovascular disease, including QTc ≥ 470 ms, LVEF < 50%, or uncontrolled hypertension.
- Active infections (e.g., HBV, HCV, HIV, tuberculosis, syphilis).
- Active or history of autoimmune diseases requiring systemic treatment.
- Severe liver disease (Child-Pugh B or C), uncontrolled diabetes, or other severe medical conditions that may interfere with the study.
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：QLS5132 Monotherapy
|
Intravenous infusion, Q3W (Day 1 of each 21-day cycle) |
|
有源比较器：QLS5132 Investigator's Choice of Chemotherapy
|
Intravenous infusion, Q4W (Day 1 of each 28-day cycle) Intravenous infusion, Q4W (Days 1, 8, 15, and 22 of each 28-day cycle) Intravenous infusion, Q4W (Days 1, 8, and 15 of each 28-day cycle) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS) Assessed by BICR
大体时间：From randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first, assessed up to approximately 3 years.
|
Time from randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first. |
From randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first, assessed up to approximately 3 years.
|
|
Overall Survival (OS)
大体时间：From randomization until death from any cause, assessed up to approximately 3 years.
|
Time from randomization to death from any cause. |
From randomization until death from any cause, assessed up to approximately 3 years.
|
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- QLS5132-301
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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