An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer
2026年6月9日 更新者:Shandong Suncadia Medicine Co., Ltd.
An Open, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-7058 in Patients With Locally Advanced or Metastatic Pancreatic Cancer Harboring KRAS G12C Mutations Who Have Failed Prior Systemic Therapy.
This is a multicenter, open-label, single-arm, phase II cilinical trial designed to evaluate the efficacy and safety of the KRAS G12C selective inhibitor HRS-7058 in patients with KRAS G12C-mutated advanced pancreatic cancer who had failed 1-2 lines of previous systemic therapy.
研究概览
研究类型
介入性
注册 (估计的)
92
阶段
- 阶段2
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。
学习联系方式
- 姓名:Keke Yan
- 电话号码:+0518-81220121
- 邮箱:keke.yan@hengrui.com
研究联系人备份
- 姓名:Meng Qin
- 电话号码:+0518-81220121
- 邮箱:meng.qin.mq8@hengrui.com
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210003
- 招聘中
- Jiangsu Province Hospital
-
首席研究员:
- Kuirong Jiang
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300060
- 招聘中
- Tianjin Medical University Cancer Institute & Hospital
-
首席研究员:
- Jihui Hao
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Informed consent was obtained from all participants before participating in the study.
- Age from 18 to 75 years old (including both ends), regardless of gender;
- Patients with locally advanced unresectable, recurrent unresectable or metastatic pancreatic cancer, and adenocarcinoma confirmed by cytology or histological pathology;
- Participants had received at least one previous systemic therapy
- At least one measurable lesion according to RECIST v1.1;
- ECOG PS score 0 or 1;
- The expected survival time was more than 3 months.
- They were able to swallow medications and were able to adhere to trial and follow-up procedures.
- Adequate bone marrow and organ function within 7 days before the first dose (no use of blood components and/or cell growth factors within 14 days before starting study treatment;
- Women of childbearing potential had to agree to abstain from sexual intercourse (heterosexual intercourse) or to use a highly effective method of contraception from the time they provided informed consent until 30 days after the last dose of the trial drug. A blood test for human chorionic gonadotropin (HCG) had to be negative within 7 days before starting study treatment and she had to be nonlactating (if a serum pregnancy test was positive, pregnancy was ruled out and enrollment was confirmed after discussion with the sponsor). Men whose partner was a woman of childbearing potential had to agree to abstain from sex or to use a highly effective method of contraception from the time they provided written informed consent until 30 days after the last dose of the trial drug. Male patients also had to agree not to donate sperm during the same period
Exclusion Criteria:
- Presence of untreated or active central nervous system (CNS) metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis, and/or spinal cord compression.
- Subjects who had received general anesthesia
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with poor blood pressure control after medication
- Subjects with abnormal clotting function
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with a history or possibility of a difficult airway
- Subject with a history of substance abuse and drug abuse
- Adrenoceptor agonists or antagonists were used before randomization
- Abnormal values in the laboratory
- Thyroid dysfunction
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Treatment group A: HRS-7058
|
HRS-7058
|
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 |
|---|---|---|
|
ORR as assessed by IRC
大体时间:About 2 years
|
IRC evaluation
|
About 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Investigator-assessed ORR
大体时间:About 2 years
|
Assessments BY INVESTIGATORS
|
About 2 years
|
|
IRC and investigator-assessed DoR
大体时间:About 2 years
|
IRC and investigator assessments
|
About 2 years
|
|
IRC and investigator-assessed DCR
大体时间:About 2 years
|
IRC and investigator assessments
|
About 2 years
|
|
IRC and investigator-assessed PFS
大体时间:About 2 years
|
IRC and investigator assessments
|
About 2 years
|
|
OS
大体时间:About 4 years
|
Assessments BY INVESTIGATORS
|
About 4 years
|
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)
2026年6月4日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年5月9日
首先提交符合 QC 标准的
2026年5月9日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月9日
最后验证
2026年5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.