Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations
研究概览
详细说明
This is a phase Ib/III, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of pan-KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in treatment-naive participants with metastatic PDAC.
Phase Ib study：an open-label study, including dose escalation and backfill cohorts, with approximately 40-80 participants planned to be enrolled (including approximately 20-50 participants in the backfill cohort),Aiming to determine the recommended phase III dose [RP3D] within investigated patient population groups.
Phase III: Following confirmation of the efficacy and safety of JAB-23E73 in combination with the AG regimen in Phase Ib, a Phase III trial will be initiated to evaluate the efficacy and safety of JAB-23E73 plus AG versus AG alone for the treatment of metastatic PDAC.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Jacobio Pharmaceuticals
- 电话号码：86 10 56315466
- 邮箱：clinicaltrials@jacobiopharma.com
学习地点
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Beijing、中国
- 招聘中
- Beijing Tsinghua Changgung Hospital
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接触：
- Beijing Tsinghua Changgung Hospital
- 电话号码：86+13366152815
- 邮箱：joelbmu@126.com
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Changsha、中国
- 尚未招聘
- Hunan Cancer Hospital
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接触：
- Hunan Cancer Hospital
- 电话号码：86+18673181133
- 邮箱：liuzhenyang@hnca.org.cn
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Harbin、中国
- 尚未招聘
- Harbin Medical University Cancer Hospital
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接触：
- Harbin Medical University Cancer Hospital
- 电话号码：86+13845120210
- 邮箱：yanqiaozhang@126.com
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Nanjing、中国
- 尚未招聘
- Jiangsu Province Hospital
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接触：
- Jiangsu Province Hospital
- 电话号码：86+13585172066
- 邮箱：Xiaofengch198019@126.com
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Shanghai、中国
- 招聘中
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
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接触：
- Shanghai Jiaotong University School of Medicine Ruijin Hospita
- 电话号码：86+13901943778 86+
- 邮箱：shenby@shsmu.edu.cn
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Taiyuan、中国
- 招聘中
- Shanxi Cancer Hospital
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接触：
- ShanXi Cancer Hospital
- 电话号码：86+13811176181
- 邮箱：WXCAMS@126.com
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Wuhan、中国
- 招聘中
- Zhongnan Hospital of Wuhan University
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接触：
- Zhongnan Hospital of Wuhan University
- 电话号码：86-13971235235 86+13971235235
- 邮箱：pjxp888@126.com
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Wuhan、中国
- 招聘中
- Wuhan Union Hospital of China
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接触：
- Wuhan Union Hospital Of China
- 电话号码：86+13720117761
- 邮箱：heshuiwu@hust.ed.cn
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Wuhan、中国
- 尚未招聘
- Hubei Province Hospital
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接触：
- Hubei Province Hospital
- 电话号码：86+15629019627
- 邮箱：971070316@qq.com
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Zhengzhou、中国
- 尚未招聘
- Henan Cancer Hospital
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接触：
- Henan Cancer Hospital
- 电话号码：86+13937100233
- 邮箱：2290773710@qq.com
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Zhengzhou、中国
- 尚未招聘
- The First Affiliated Hospital of Zhengzhou University
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接触：
- The First Affiliated hospital of Zhengzhou University
- 电话号码：86+13676932999
- 邮箱：yanruqin@163.com
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100142
- 招聘中
- Beijing Cancer Hospital
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接触：
- Beijing Cancer Hospital
- 电话号码：86+13911219511
- 邮箱：doctorshenlin@sina.com
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Zhejiang
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Hangzhou、Zhejiang、中国、310005
- 尚未招聘
- Zhejiang Cancer Hospital
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接触：
- Zhejiang Cancer Hospital
- 电话号码：86+13858195803
- 邮箱：hzyingjieer@163.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
1.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.
3. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).
5. ECOG performance status score of 0 or 1. 6. Adequate organ function.
Exclusion Criteria:
- Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
- A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
- Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class.
- Women who are pregnant or breast-feeding.
- Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Dose escalation/backfill
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Orally, intravenous (IV) infusion
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dose limiting toxicities (DLT)
大体时间：Up to 28 days
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The number and proportion of participants who experienced dose-limiting toxicities (DLT).
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Up to 28 days
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Adverse events.safety evaluation
大体时间：Up to approximately 3 years
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The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
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Up to approximately 3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ORR
大体时间：Up to approximately 3 years
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Objective response rate, ORR is defined as the proportion of participants with confirmed complete response or partial response
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Up to approximately 3 years
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DOR
大体时间：Up to approximately 3 years
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Duration of response, DOR is defined as the time from the first documented CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first
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Up to approximately 3 years
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TTR
大体时间：Up to approximately 3 years
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Time to Response, TTR is defined as the time from the first dose of study treatment to the first documented CR or PR.
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Up to approximately 3 years
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PFS
大体时间：Up to approximately 3 years
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Progression-Free Survival , PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
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Up to approximately 3 years
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DCR
大体时间：Up to approximately 3 years
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Disease Control Rate, DCR is defined as the proportion of participants whose best overall response is CR, PR, or SD..
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Up to approximately 3 years
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OS
大体时间：Up to approximately 3 years
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Overall Survival , OS is defined as the time from the first dose of study treatment to death from any cause.
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Up to approximately 3 years
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PK
大体时间：Up to approximately 3 years
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maximum plasma concentration (Cmax)
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Up to approximately 3 years
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PK
大体时间：Up to approximately 3 years
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area under the plasma concentration-time curve (AUC)
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Up to approximately 3 years
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PK
大体时间：Up to approximately 3 years
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trough plasma concentration (Ctrough)
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Up to approximately 3 years
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合作者和调查者
调查人员
- 研究主任：Jacobio Pharmaceuticals、Jacobio Pharmaceuticals
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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