A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
2022年9月26日 更新者：Jacobio Pharmaceuticals Co., Ltd.
A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation.
研究概览
详细说明
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..
研究类型
介入性
注册 (预期的)
104
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing
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Beijing、Beijing、中国、100101
- 招聘中
- Research site01
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Beijing、Beijing、中国、100010
- 尚未招聘
- Research site08
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Beijing、Beijing、中国、100010
- 尚未招聘
- Research site09
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Beijing、Beijing、中国、100032
- 尚未招聘
- Research site021
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Beijing、Beijing、中国、100089
- 尚未招聘
- Research site02
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Beijing、Beijing、中国、101100
- 尚未招聘
- Research site013
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Chongqing
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Chongqing、Chongqing、中国、400000
- 尚未招聘
- Research site010
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Fujian
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Xiamen、Fujian、中国、361000
- 尚未招聘
- Research site05
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Guangdong
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Shenzhen、Guangdong、中国、518000
- 尚未招聘
- Research site011
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Guangxi
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Nanning、Guangxi、中国、530000
- 尚未招聘
- Research site016
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Hebei
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Shijiazhuang、Hebei、中国、050000
- 尚未招聘
- Research site017
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Heilongjiang
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Ha'erbin、Heilongjiang、中国、150000
- 尚未招聘
- Research site018
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Henan
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Zhengzhou、Henan、中国、450000
- 尚未招聘
- Research site04
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Hunan
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Changsha、Hunan、中国、410000
- 尚未招聘
- Research site012
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Jilin
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Changchun、Jilin、中国、130000
- 尚未招聘
- Research site015
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Liaoning
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Shenyang、Liaoning、中国、110000
- 尚未招聘
- Research site06
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Shenyang、Liaoning、中国、110000
- 尚未招聘
- Research site07
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Neimenggu
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Hohhot、Neimenggu、中国、010000
- 尚未招聘
- Research site014
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Shanxi
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Xi'an、Shanxi、中国、710000
- 尚未招聘
- Research site020
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Wuhan
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Hubei、Wuhan、中国、430060
- 尚未招聘
- Research site03
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- 尚未招聘
- Research site019
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
- STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
- Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
- ECOG 0-1
Exclusion Criteria:
- Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
- Any severe and/or uncontrolled medical conditions
- Active infection requiring systemic treatment within 7 days
- Therapeutic radiation therapy within 3 weeks of study day 1
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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：Phase 1 ,Dose Exploration ,monotherapy
Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D
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Administered orally
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实验性的：Phase 2, Dose Expansion, Part1 monotherapy
Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC)
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Administered orally
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实验性的：Phase 2 Dose Expansion, Part 2 monotherapy
Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC
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Administered orally
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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 Escalation phase Number of participants with dose limiting toxicities (DLTs)
大体时间：At the end of Cycle 1 (each cycle is 21 days)
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A DLT is defined as the clinically significant treatment-related adverse event or abnormal laboratory values assessment during the first 21 days of Cycle 1.
It excludes adverse events (AEs) that are deemed clearly related to underlying disease, progression, or intercurrent illness.
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At the end of Cycle 1 (each cycle is 21 days)
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Dose Escalation phase: Number of participants with adverse events
大体时间：Up to 3 years
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Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
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Up to 3 years
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Dose Expansion phase: Objective response rate (ORR)
大体时间：Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
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ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
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Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
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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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Dose Escalation phase: Objective response rate (ORR)
大体时间：Up to 3 years - from baseline to RECIST confirmed Progressive Disease
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ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
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Up to 3 years - from baseline to RECIST confirmed Progressive Disease
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Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
大体时间：Up to 3 years
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PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST1.1 or death whichever occurs first
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Up to 3 years
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Dose Escalation and Dose Expansion phase: Duration of response (DOR)
大体时间：Up to 3 years
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DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
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Up to 3 years
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Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
大体时间：Up to 3 years
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DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
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Up to 3 years
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Dose Escalation and Dose Expansion phase: Overall Survival (OS)
大体时间：Up to 3 years
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Defined as time from first treatment to death by any cause
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Up to 3 years
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Dose Escalation and Dose Expansion phase: Time to response (TTR)
大体时间：Up to 3 years
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Defined as time from first treatment to first evidence of PR or CR
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Up to 3 years
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Dose Expansion phase: Number of participants with adverse events
大体时间：Up to 3 years
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Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
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Up to 3 years
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Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)
大体时间：Up to 3 Years
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Cmax of JAB-21822 will be measured by using plasma PK samples
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Up to 3 Years
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Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)
大体时间：Up to 3 Years
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Tmax of JAB-21822 will be measured by using plasma PK samples
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Up to 3 Years
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Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)
大体时间：Up to 3 Years
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AUC of JAB-21822 will be measured by using plasma PK samples
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Up to 3 Years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年8月17日
初级完成 (预期的)
2023年12月1日
研究完成 (预期的)
2026年2月1日
研究注册日期
首次提交
2022年3月3日
首先提交符合 QC 标准的
2022年3月3日
首次发布 (实际的)
2022年3月11日
研究记录更新
最后更新发布 (实际的)
2022年9月28日
上次提交的符合 QC 标准的更新
2022年9月26日
最后验证
2022年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
JAB 21822的临床试验
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Jacobio Pharmaceuticals Co., Ltd.招聘中
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Jacobio Pharmaceuticals Co., Ltd.招聘中
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Jacobio Pharmaceuticals Co., Ltd.招聘中
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Jacobio Pharmaceuticals Co., Ltd.招聘中
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Jacobio Pharmaceuticals Co., Ltd.招聘中