NCT07689539尚未招募3 期
A Phase 3, Multicenter, Open-Label, Randomized, Controlled Trial of DN022150 Monotherapy Versus Investigator's Choice Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation
Jiangxi Kvvit Pharmaceutical Co., Ltd.0 个研究点目标入组 360 人开始时间: 2026年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy
详细描述
This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy
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
- None
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 received prior systemic 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
- •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
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: up to 2 years
Evaluated by Blinded Independent Central Review (BIRC)
Overall Survival (OS)
时间窗: up to 2 years
次要结局
- Cmax(Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）)
- Cmin(Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）)
- t1/2(Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）)
- Duration of Response (DoR)(up to 2 years)
- Disease Control Rates (DCR)(up to 2 years)
- Time to Response (TTR）(up to 2 years)
- Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0(up to 2 years)
- AUC0-t(Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）)
- AUC0-inf(Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）)
- Progression-Free Survival (PFS)(up to 2 years)
- Objective Response Rate (ORR)(up to 2 years)
- EORTC QLQ-C30（European Organization for Research and Treatment of Cancer Quality of Life Questionnaire）(up to 2 years)
- EORTC QLQ-PAN26（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer 26）(up to 2 years)
研究者
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