An Open-label, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The number of subjects with dose-limiting toxicity (DLT)
研究概览
简要总结
This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years old, gender not limited;
- •Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.
- •Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;
- •Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.
- •Have at least one measurable lesion as per RECIST v1.1;
- •ECOG PS score: 0-1;
- •Good organ function level.
排除标准
- •Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;
- •Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;
- •Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;
- •Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;
- •Participants who have experienced severe infections within one month prior to the first medication.
研究组 & 干预措施
SHR-8203 Injection
干预措施: SHR-8203 Injection (Drug)
结局指标
主要结局
The number of subjects with dose-limiting toxicity (DLT)
时间窗: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Incidence and severity of AEs
时间窗: From the first visit to the end of the safety follow-up period (1 year)
Maximum Tolerated Dose
时间窗: During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）
Determination of Recommended Phase II dose (RP2D)
时间窗: After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).
Objective Response Rate (ORR)
时间窗: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
次要结局
- Duration of Response (DoR)(From time of first dose of objective disease progression until the date of objective disease progression or death (1 year))
- Disease Control Rate (DCR)(From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year))
- Progression free Survival (PFS)(From time of first dose of objective disease progression until the date of objective disease progression or death (1 year))
- Overall Survival (OS)(From time of first dose of objective disease progression until the date of death (2 years))