NCT07589569招募中2 期
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.
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2026年6月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- ORR as assessed by IRC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
Treatment group A: HRS-7058
Experimental
干预措施: HRS-7058 (Drug)
结局指标
主要结局
ORR as assessed by IRC
时间窗: About 2 years
IRC evaluation
次要结局
- Investigator-assessed ORR(About 2 years)
- IRC and investigator-assessed DoR(About 2 years)
- IRC and investigator-assessed DCR(About 2 years)
- IRC and investigator-assessed PFS(About 2 years)
- OS(About 4 years)
研究者
研究点 (2)
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