NCT06770569招募中1 期
A Single-arm, Open-Label, Multi-center Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors
Shandong Suncadia Medicine Co., Ltd.11 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2025年1月21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
- 100
- 试验地点
- 11
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.
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
- •Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits;
- •Age ≥18 years, male or female;
- •Patients with advanced malignant tumors confirmed pathologically;
- •Failure of adequate standard treatment, or no effective standard treatment;
- •Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1;
- •The expected survival period is more than 12 weeks;
- •The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
- •Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days);
- •Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 1 months after the last administration of the study drug Measures.
排除标准
- •Subjects had cancerous meningitis or untreated central nervous system metastases;
- •Subjects had severe cardiovascular and cerebrovascular diseases;
- •There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion);
- •Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia;
- •Arteriovenous thrombosis occurred within 6 months prior to the first dose;
- •Severe infection occurred within 4 weeks prior to initial administration;
- •Subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome;
- •Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS);
- •Subjects had active hepatitis;
- •Subjects were scheduled to receive other systemic antitumor therapies during the study period;
- •Known allergies and contraindications to the investigational drug or any of its components;
- •Other factors as judged by the investigator that may lead to the termination of the study, such as other serious diseases, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subject, or the collection of study data and samples.
研究组 & 干预措施
HRS-3802
Experimental
干预措施: HRS-3802 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: During the first 28-day cycle of HRS-3802 treatment
Number of subjects with adverse events and the severity of adverse events
时间窗: Every 4 weeks after treatment initiation (through study completion，an average 5 mouths)
Maximum tolerated dose (MTD)
时间窗: 3 weeks after treatment initiation
Recommended Phase II Dose (RP2D)
时间窗: 3 weeks after treatment initiation
次要结局
- Objective response rate (ORR) - RECIST 1.1(Up to approximately 6 months)
- Progression-free survival (PFS) per RECIST 1.1(Up to approximately 2 years)
- Duration of Response (DoR) per RECIST 1.1(Up to approximately 2 years)
研究者
研究点 (11)
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