A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study and sign the informed consent form.
- •Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.
- •Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.
- •Have received at least one prior standard systemic therapy.
- •Participants must have at least one measurable lesion (per RECIST 1.1 criteria).
- •Expected survival time ≥ 12 weeks as judged by the investigator.
- •Have adequate organ function
排除标准
- •Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
- •With active central nervous system (CNS) metastasis.
- •Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.
- •Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.
- •Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.
- •With clinically significant severe cardiovascular diseases.
- •Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.
- •Complicated with major acute or chronic infectious diseases.
- •Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.
- •Pregnant or lactating females.
- •Other conditions deemed inappropriate for participation in the study by the investigator.
研究组 & 干预措施
Chemotherapy
There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator.
干预措施: Chemotherapy (Drug)
GFH375
GFH375, Oral tablets
干预措施: GFH375 (Drug)
结局指标
主要结局
OS
时间窗: Up to approximately 2 years
Overall Survival
PFS
时间窗: Up to approximately 2 years
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR
次要结局
- PFS(Up to approximately 2 years)
- DoR(Up to approximately 2 years)
- TTR(Up to approximately 2 years)
- DCR(Up to approximately 2 years)
- EORTC QLQ-C30 Score(Up to approximately 2 years)
- Plasma concentrations of GFH375(Up to approximately 2 years)
- ORR(Up to approximately 2 years)
- The incidence and severity of AEs and SAEs(Up to approximately 2 years)
- EORTC QLQ-PAN26 Score(Up to approximately 2 years)