A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Objective response rate
研究概览
简要总结
In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen 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
- 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
- •Subject aged between 18 and 75 years.
- •Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- •Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
- •Subject has an ECOG score of 0-1 and is expected to survive more than 3 months;
- •Subjects have a good level of organ function.
排除标准
- •Subject suitable for potentially curative surgery.
- •The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.
- •The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.
研究组 & 干预措施
GroupA (YL-13027+AG )
YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: YL-13027 (Drug)
GroupA (YL-13027+AG )
YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Gemcitabine (Drug)
GroupA (YL-13027+AG )
YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Nab-paclitaxel (Drug)
Group B (HY-0102+AG )
HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: HY-0102 (Drug)
Group B (HY-0102+AG )
HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Gemcitabine (Drug)
Group B (HY-0102+AG )
HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Nab-paclitaxel (Drug)
Group C (YL-13027+HY-0102+AG)
YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: YL-13027 (Drug)
Group C (YL-13027+HY-0102+AG)
YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: HY-0102 (Drug)
Group C (YL-13027+HY-0102+AG)
YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Gemcitabine (Drug)
Group C (YL-13027+HY-0102+AG)
YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Nab-paclitaxel (Drug)
Group D (AG)
Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Gemcitabine (Drug)
Group D (AG)
Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Objective response rate
时间窗: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
The proportion of subjects who have a complete response or partial response.
Progression-free survival
时间窗: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Progression-free survival is defined clinically as the time from randomization to disease progression or death from any cause
次要结局
- Disease control rate(From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.)
- Adverse events(From time of first dose to 30 days after the last dose.)
- Plasma concentration of YL-13027 and HY-0102(From one hour before the first dose to the last dose up to 24months.)