A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
2026年9月2日 更新者:MediLink Therapeutics (Suzhou) Co., Ltd.
A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy
The purpose of this study is to evaluate the safety and efficacy of an investigational B7-H3 antibody drug-conjugate administered as monotherapy, compared with standard of care (SOC) chemotherapy in metastatic pancreatic cancer patients who have failed prior Gemcitabine-based systemic therapy.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
320
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:MediLink Study Team
- 电话号码:+86 512 62858368
- 邮箱:clinicaltrials@medilinkthera.com
学习地点
-
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200127
- Shanghai Jiaotong University School of Medicine
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接触:
- Study Coordinator
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
- Participants must be ≥18 and ≤75 years of age.
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
- Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Participants must have adequate organ function as defined in the protocol.
- Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion Criteria:
- Participants with another malignancy within 5 years before randomization.
- Participants with pathologically confirmed pancreatic cancer other than PDAC.
- Participants who have previously received B7-H3-targeted therapy.
- Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
- Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study.
- Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study.
- Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases.
- Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks.
- Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
- Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
- Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:Tambotatug pelitecan
Tambotatug pelitecan, monotherapy
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Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
其他名称:
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有源比较器:Chemotherapy
Active comparator: nal-IRI+5-FU/LV
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Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. 5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. |
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 |
|---|---|---|
|
PFS by BICR
大体时间:Up to approximately 2 years
|
Progression-free Survival (PFS) is assessed by Blinded Independent Central Review(BICR) per response evaluation criteria in solid tumors (RECIST) v1.1
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Up to approximately 2 years
|
|
OS
大体时间:Up to approximately 2 years
|
OS is defined as the time from randomization until death from any cause.
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Up to approximately 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PFS by investigator
大体时间:Up to approximately 2 year
|
PFS per RECIST v1.1, as assessed by Investigator
|
Up to approximately 2 year
|
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ORR
大体时间:Up to approximately 2 years
|
Objective Response Rate (ORR), as assessed by BICR and Investigator
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Up to approximately 2 years
|
|
DCR
大体时间:Up to approximately 2 years
|
Disease Control Rate (DCR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
DoR
大体时间:Up to approximately 2 years
|
Duration of Response (DoR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
TTR
大体时间:Up to approximately 2 years
|
Time to Response (TTR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
Adverse Event
大体时间:Up to approximately 2 years
|
The incidence and severity of AEs, SAEs and AESIs per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
|
Up to approximately 2 years
|
|
To evaluate the AUC
大体时间:Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Cmax
大体时间:Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Ctrough
大体时间:Up to approximately 2 years
|
Up to approximately 2 years
|
|
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To evaluate the CL
大体时间:Up to approximately 2 years
|
Up to approximately 2 years
|
|
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To evaluate the Vd
大体时间:Up to approximately 2 years
|
Up to approximately 2 years
|
|
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To evaluate the t1/2
大体时间:Up to approximately 2 years
|
Up to approximately 2 years
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Immunogenicity
大体时间:Up to approximately 2 years
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Incidence of anti-drug antibodies of YL201
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Up to approximately 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2029年1月1日
研究完成 (估计的)
2029年5月1日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
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