NCT07123129招募中1 期
An Open-label, Multicenter Phase I Clinical Study of SHR-7782 Injection in the Treatment of Advanced Malignant Cancer
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Dose Limited Toxicity (DLT)
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.
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
- •Participate in the study voluntarily, sign the informed consent form.
- •Subjects were able to provide primary or metastatic cancer samples.
- •At least one measurable lesion (RECIST version 1.1).
- •With adequate organ functions.
- •Expected survival time ≥ 12 weeks.
排除标准
- •With untreated brain metastasis or active central nervous system tumor metastases.
- •Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
- •Patients with other malignant tumors in the past or at the same time.
- •Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
- •Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- •With poorly controlled or severe cardiovascular disease.
- •Bleeding events of NCI-CTCAE v5.0 grade ≥ 2 occurred within 1 month before the first medication.
- •Subjects who had a serious infection within 1 month before the first medication.
- •History of immunodeficiency.
- •Known allergy to any component of the SHR-7782 product.
- •According to the researcher's judgment, there are other factors that may affect the research results or cause the research to be terminated midway.
研究组 & 干预措施
SHR-7782 Group
Experimental
干预措施: SHR-7782 Injection (Drug)
结局指标
主要结局
Dose Limited Toxicity (DLT)
时间窗: Up to 21 days.
Maximum Tolerated Dose (MTD)
时间窗: Up to 6 months.
Recommended Phase II Dose (RP2D)
时间窗: Up to 21 days.
次要结局
- Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria(Up to approximately 24 months.)
- Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria(Up to approximately 24 months.)
- Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria(Up to approximately 24 months.)
- Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria(Up to approximately 24 months.)
- Overall Survival (OS)(Up to approximately 24 months.)
研究者
研究点 (2)
Loading locations...
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