NCT05851092招募中1 期
A Single Arm, Open, Multicenter Phase I Clinical Study on the Safety, Tolerance, and Pharmacokinetics of HRS-2189 Single Drug in Patients With Advanced Malignant Solid Tumors
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月26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
- 60
- 试验地点
- 1
- 主要终点
- Recommended Phase II Dose (RP2D) of HRS-2189
研究概览
简要总结
This study is a multi center, open label, dose increasing/dose expanding/efficacy expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in patients with advanced malignant solid tumors. This study was divided into three stages: dose escalation, dose expansion, and efficacy expansion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this study, sign an informed consent form, have good compliance, and can cooperate with follow-up
- •Age ≥ 18 years old (including boundary value, calculated based on the date of signing informed consent), Male or female
- •ECOG score: 0-1
- •Expected survival ≥ 12 weeks
- •Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology and not resectable, and currently fails to undergo standard treatment or has no standard treatment plan
- •If enrolled in ER positive and HER2 negative female breast cancer subjects, they need to meet the criteria defined in the guidelines of the American Association of Clinical Oncology/American College of Pathologists
- •Baseline presence of at least one extracranial measurable lesion that meets the RECIST v1.1 standard
- •The functional level of important organs is basically normal, meeting the requirements of the scheme
- •Previous treatment: Before the first medication in this study, the interval between receiving nitrosourea or mitomycin C ≥ 6 weeks; Receiving cytotoxic drugs, endocrine therapy, immunotherapy, targeted therapy, surgical interval (except puncture biopsy or PICC catheterization or PORT infusion port catheterization) or other clinical studies with the last medication ≥ 4 weeks; Interval from the end of radiotherapy ≥ 2 weeks
- •Adverse events caused by other treatments for the subject returned to a severity level of NCI-CTCAE V5.0 ≤ 1 (excluding hair loss and other adverse events judged tolerable by the investigator)
- •Female subjects with fertility must agree to use highly effective contraception during the study treatment period and within 7 months after the last medication; Male subjects must agree to use highly effective contraception during the study treatment period and 4 months after the last medication; Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation. If the serum HCG is weakly positive, it is necessary for the researcher to evaluate and judge it as a non pregnant state, and urine HCG should be tested before medication, with a negative result
- •Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent
排除标准
- •Subjects with cancerous meningitis or untreated central nervous system metastasis
- •Uncontrolled pleural, abdominal, and pericardial effusion
- •Clinical symptoms or diseases of the heart that are not well controlled
- •Arterial/venous thrombotic events occurred within 6 months before the first medication administration
- •Active infection or unexplained fever>38.5 ° C occurred within 4 weeks before or on the day of the first medication (subjects with tumor fever are judged by the investigator to be included in the study)
- •Subjects with congenital or acquired immune dysfunction (such as HIV infected persons); Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- •Subject has active hepatitis
- •Subjects had other malignant tumors within the past 3 years, except for fully treated basal or squamous cell skin cancer or cervical carcinoma in situ
- •Those who are unable to swallow tablets normally or have gastrointestinal dysfunction that may affect drug absorption according to the judgment of the researcher
- •Patients participating in the QT/QTc study have used any medication that has the risk of prolonging the QT/QTc interval or causing torsade de pointe (TdP) within 4 weeks before the first medication, have a previous history of congenital QT interval prolongation syndrome or a family history of QT interval prolongation, have an implanted pacemaker or automatic implantable cardioverter defibrillator, and cannot correct electrolyte disturbances that affect the QT/QTc study
- •Pregnant and lactating women, or planning to become pregnant during the study period
- •According to the judgment of the researcher, the subject has other factors that may lead to the forced termination of this study
研究组 & 干预措施
HRS-2189 Tablets
Experimental
干预措施: HRS-2189 Tablets (Drug)
结局指标
主要结局
Recommended Phase II Dose (RP2D) of HRS-2189
时间窗: up to 35 days
AEs+SAEs
时间窗: from the first drug administration to within 30 days for the last treatment dose
Dose limited toxicity (DLT) of HRS-2189
时间窗: up to 35 days
Maximum tolerated dose（MTD）of HRS-2189
时间窗: up to 35 days
次要结局
- Progression free survival（PFS）(every 8 weeks since Day 8 administration,an average of 1 year)
- Evaluation of pharmacokinetic parameter of HRS-2189: Tmax(2 months)
- Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-t(2 months)
- Evaluation of pharmacokinetic parameter of HRS-2189: Cmax(2 months)
- Evaluation of pharmacokinetic parameter of HRS-2189: Tmax,ss(2 months)
- Evaluation of pharmacokinetic parameter of HRS-2189: Cmin,ss(2 months)
- Disease control rate (DCR)(every 8 weeks since Day 8 administration,an average of 1 year)
- Evaluation of pharmacokinetic parameter of HRS-2189: Cmax,ss(2 months)
- Evaluation of pharmacokinetic parameter of HRS-2189: AUCss(2 months)
- Objective Response Rate (ORR)(every 8 weeks since Day 8 administration,an average of 1 year)
- Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-inf(2 months)
- Evaluation of pharmacokinetic parameter of HRS-2189: Rac(2 months)
- Bioavailability of HRS-2189 on an empty stomach and after meals(up to 9 days)
- Duration of response (DoR)(every 8 weeks since Day 8 administration,an average of 1 year)
研究者
研究点 (1)
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