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Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation

2026年6月15日 更新者:Jiangxi Kvvit Pharmaceutical Co., Ltd.
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I :explores the combination dose and the second phase; Stage II :patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.

研究概览

研究类型

介入性

注册 (估计的)

465

阶段

  • 阶段2
  • 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

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:

  1. Voluntarily signed informed consent form
  2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent
  3. Life expectancy ≥ 12 weeks
  4. Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
  5. ECOG score of performance status 0 ~ 1
  6. At least one measurable lesion by RECIST v1.1 criteria
  7. Adequate organ function
  8. Effective methods of contraception during the study

Exclusion Criteria:

  1. Progression or other malignancy requiring treatment within 5 years prior to enrollment
  2. Prior targeted therapy for KRAS G12D
  3. With central nervous system metastasis
  4. Uncontrolled fluid accumulation
  5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
  6. Concomitant clinically significant cardiovascular disease
  7. Concurrent major acute or chronic infectious disease
  8. 4. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
  9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
  10. Other situations not suitable for the study judged by the investigator

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:DN022150+AG( Stage I )
Stage I,To evaluate the safety and tolerability of two different doses of DN022150 for Injection combined with AG regimen preset, and to determine the recommended dose of DN022150 for Injection combined with AG regimen for efficacy expansion based on the PK and preliminary efficacy data. After the completion of efficacy expansion, the safety, tolerability, PK and preliminary efficacy data of the first phase will be synthesized to confirm the RP3D of DN022150 combined with AG regimen
28-day /cycle
其他名称:
  • Dose-finding group
实验性的:DN022150+AG( Stage II)
Stage II DN022150( RP3D)+AG
28-day /cycle
其他名称:
  • 测试组
安慰剂比较:DN022150 placebo+AG( Stage II)
Stage II DN022150 placebo+AG
28-day /cycle
其他名称:
  • 控制组

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
DLT
大体时间:up to 2 years
stage I :To evaluate the safety and tolerability of different doses of DN022150 for Injection combined with AG regimen in participants with locally advanced or metastatic pancreatic cancer, including the incidence of dose limiting toxicity (DLT), explore the MTD, and determine the RP3D of DN022150 for Injection combined with AG regimen in combination with PK and efficacy data
up to 2 years
PFS as assessed by BICR per RECIST 1.1
大体时间:up to 2 years
stage II
up to 2 years
OS
大体时间:up to 2 years
stage II
up to 2 years
ORR
大体时间:up to 2 years
stage I
up to 2 years

次要结果测量

结果测量
措施说明
大体时间
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
大体时间:up to 2 years
stage I&II
up to 2 years
DOR as assessed by the investigator per RECIST v1.1
大体时间:up to 2 years
stage I
up to 2 years
Cmin, ss
大体时间:up to 2 year
stage I&II: Steady State Trough Concentration
up to 2 year
Pancreatic cancer quality of life specific scale
大体时间:up to 2 years
stage II
up to 2 years
DCR as assessed by the investigator per RECIST v1.1
大体时间:up to 2 years
stage I
up to 2 years
PFS assessed by the investigator per RECIST v1.1
大体时间:up to 2 years
stage I
up to 2 years
OS
大体时间:up to 2 years
stage I
up to 2 years
PFS as assessed by the investigator per RECIST v1.1
大体时间:up to 2 years
stage II
up to 2 years
ORR as assessed by the investigator or BICR per RECIST v1.1
大体时间:up to 2 years
stage II
up to 2 years
DOR as assessed by the investigator or BICR per RECIST v1.1
大体时间:up to 2 years
stage II
up to 2 years
DCR as assessed by the investigator or BICR per RECIST v1.1
大体时间:up to 2 years
stage II
up to 2 years
Cmax,ss
大体时间:up to 2years
Maximum Steady-State Plasma Concentration
up to 2years
AUC0-t
大体时间:up to 2years
stage I&II AUC from time 0 to last measurable time
up to 2years
t1/2
大体时间:up to 2years
stageI&II Half-life
up to 2years

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)

2027年6月6日

初级完成 (估计的)

2029年2月7日

研究完成 (估计的)

2029年5月8日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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