NCT07656376尚未招募2 期
Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation
Jiangxi Kvvit Pharmaceutical Co., Ltd.0 个研究点目标入组 465 人开始时间: 2027年6月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 465
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed informed consent form
- •Age 18-75 years (inclusive), male or female, at the time of signing informed consent
- •Life expectancy ≥ 12 weeks
- •Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
- •ECOG score of performance status 0 ~ 1
- •At least one measurable lesion by RECIST v1.1 criteria
- •Adequate organ function
- •Effective methods of contraception during the study
排除标准
- •Progression or other malignancy requiring treatment within 5 years prior to enrollment
- •Prior targeted therapy for KRAS G12D
- •With central nervous system metastasis
- •Uncontrolled fluid accumulation
- •Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
- •Concomitant clinically significant cardiovascular disease
- •Concurrent major acute or chronic infectious disease
- •4. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
- •History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
- •Other situations not suitable for the study judged by the investigator
研究者
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