NCT06383871招募中1 期
An Open, Multicenter Phase I Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-7058 Monotherapy in Patients With Advanced Solid Tumour With KRAS G12C Mutation
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2024年6月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- maximum tolerated dose (MTD)
研究概览
简要总结
This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
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
- •The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
- •18 to 75 years old (including both ends), gender is not limited;
- •Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
- •Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
- •ECOG Performance Status of 0 or 1;
- •The expected survival time is more than 3 months;
- •Be able to ingest drugs and be able to comply with trial and follow-up procedures;
- •Adequate bone marrow and organ function;
- •Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;
- •For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.
排除标准
- •Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
- •Had other malignancies within five years prior to first use of the investigational drug;
- •With severe cardiovascular and cerebrovascular disease；
- •Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
- •The presence of uncontrolled pleural, abdominal or pericardial effusion;
- •Severe infection within 4 weeks prior to initiation of study treatment;
- •History of immune deficiency;
- •The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
- •Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug;
- •Had undergone major organ surgery within 4 weeks prior to the first use of the study drug;
- •Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period;
- •Known allergies and contraindications to the investigational drug or any of its components;
- •In the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the study.
研究组 & 干预措施
HRS-7058
Experimental
干预措施: HRS-7058 capsule/ HRS-7058 tablet (Drug)
结局指标
主要结局
maximum tolerated dose (MTD)
时间窗: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Phase II recommended dose (RP2D)
时间窗: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Dose-limiting toxicity (DLT)
时间窗: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Safety endpoints: adverse events (AE)
时间窗: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months]
次要结局
- Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion(From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months)
- Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion(From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months)
- Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion(From the beginning of first patient in (FPI) to the end of study up to approximately 21 months)
- Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion(From the beginning of first patient in (FPI) to the end of study up to approximately 21 months)
- Efficacy endpoints: overall survival (OS)(From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months)
研究者
研究点 (1)
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