A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination with Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- MTD & Safety assessment (Phase I)
研究概览
简要总结
This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.
详细描述
The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.
Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.
At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.
Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase I-1 (#4 Cohort)
BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
干预措施: BEY1107 (Drug)
Phase I-2 (#3 Cohort)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
干预措施: BEY1107 (Drug)
Phase I-2 (#3 Cohort)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
干预措施: Gemcitabine (Combination Product)
Phase II (#1 Cohort)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
干预措施: BEY1107 (Drug)
Phase II (#1 Cohort)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
干预措施: Gemcitabine (Combination Product)
结局指标
主要结局
MTD & Safety assessment (Phase I)
时间窗: 0
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
时间窗: 0
次要结局
- Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)(0)
- ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)(0)
- Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)(0)
- DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)(0)
- AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)(0)