NCT07784374尚未招募2 期
A Phase II, Multicenter, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of GFH375 in Combination With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.
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
- •Able to provide written informed consent prior to any study-related procedures.
- •Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent.
- •Histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Estimated life expectancy ≥ 3 months as judged by the investigator.
- •Has received at least 1 prior line of systemic anti-tumor therapy.
- •Has at least one measurable lesion per RECIST version 1.
- •Adequate organ function.
排除标准
- •Other malignancy that has progressed or required treatment within 3 years prior to study entry.
- •Active central nervous system (CNS) metastases.
- •Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
- •Clinically significant severe cardiovascular disease.
- •Stroke or other severe cerebrovascular events within 6 months prior to randomization.
- •Significant acute or chronic infectious disease.
- •Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse.
- •Pregnant or lactating female subjects.
- •Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.
研究组 & 干预措施
GFH375+GFH276
Experimental
干预措施: GFH276 (Drug)
GFH375+GFS202A
Experimental
干预措施: GFS202A (Drug)
GFH375
Experimental
干预措施: GFH375 (Drug)
GFH375+GFH276
Experimental
干预措施: GFH375 (Drug)
GFH375+GFS202A
Experimental
干预措施: GFH375 (Drug)
结局指标
主要结局
PFS
时间窗: Up to approximately 2 years
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1
Weight
时间窗: Baseline, From first study treatment to Week 12
Percentage Change in Body Weight From Baseline at Week 12
次要结局
- Plasma concentration of GFH375(Up to approximately 2 years)
- Plasma concentration of GFH276(Up to approximately 2 years)
- OS(Up to approximately 3 years)
- PFS(Up to approximately 2 years)
- ORR(Up to approximately 2 years)
- DCR(Up to approximately 2 years)
- DoR(Up to approximately 2 years)
- TTR(Up to approximately 2 years)
- FAACT Scores(Up to approximately 2 years)
- L3SMI(Up to approximately 2 years)
- Change in third-lumbar-level fat area(Up to approximately 2 years)
- The incidence and severity of AEs and SAEs(Up to approximately 2 years)
- Plasma concentration of GFS202A(Up to approximately 2 years)
研究者
研究点 (1)
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