An Exploratory Clinical Study of HRS-4642 in Combination With SHR-A2102 for the Treatment of Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Dose Limited Toxicity(DLT)
研究概览
简要总结
The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors
详细描述
This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.
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
- •Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
- •The age of signing the informed consent is from 18 to 75 years old, regardless of gender
- •Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
- •The ECOG score is 0 or 1
- •Expected survival ≥12 weeks
- •At least one measurable lesion according to RECIST v1.1 criteria
- •Good level of organ function
- •Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods
排除标准
- •subjects with uncontrolled or active brain metastasis；
- •subjects with clinical significant lung disease;
- •subjects with history of autoimmune diseases;
- •Known active hepatitis B or C infection;
- •Subjects with severe cardiovascular and cerebrovascular diseases
- •Uncontrolled tumor-related pain
- •Severe infections that require intravenous antibiotic, antiviral or antifungal control
- •Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
- •Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- •Known allergic to any compound of SHR-A2102 or HRS-4642
- •Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment
研究组 & 干预措施
Treatment group
SHR-A2102+HRS-4642
干预措施: SHR-A2102+HRS-4642 (Drug)
结局指标
主要结局
Dose Limited Toxicity(DLT)
时间窗: At the end of Cycle 1 (each cycle is 14 days)
one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.
Objective Response Rate (ORR)
时间窗: up to 1 year
the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
- Progression-free Survival (PFS)(up to 2 year)
- Overall survival(OS)(up to 2 year)
- Disease Control Rate (DCR)(up to 1 year)
- Duration of response (DoR)(up to 1 year)
- Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory(Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 2 years.)