NCT07068932招募中1 期
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4506 Injection in Patients With Malignant Tumors
适应症
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
- 102
- 试验地点
- 4
- 主要终点
- Dose Limited Toxicities (DLTs)
研究概览
简要总结
The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
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
- •Age ≥18 years, any gender.
- •ECOG performance status 0-
- •Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
- •Adequate organ function.
- •Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
- •Expected survival ≥12 weeks.
- •Patients in the dose-expansion phase must have measurable lesions.
- •Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.
排除标准
- •Prior treatment with the same class of investigational drug.
- •Confirmed or suspected central nervous system (CNS) tumor involvement.
- •Uncontrolled tumor-related pain.
- •Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
- •Clinically significant cardiovascular disease history.
- •Known hypersensitivity to any component of the investigational drug.
- •Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
- •Adverse events from prior therapy have not recovered to ≤ CTCAE Grade
- •Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
- •History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
- •Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
- •Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.
研究组 & 干预措施
SHR-4506 Group
Experimental
干预措施: SHR-4506 Injection (Drug)
结局指标
主要结局
Dose Limited Toxicities (DLTs)
时间窗: Up to 21 days.
Maximum Tolerated Dose (MTD)
时间窗: Up to 21 days.
Incidence and severity of adverse events (AEs)
时间窗: Up to 90 days after the last dose.
Incidence and severity of serious adverse events (SAEs)
时间窗: Up to 90 days after the last dose.
次要结局
- Objective response rate (ORR) assessed by the investigator(Up to 3 years.)
- Objective tumor response duration (DoR)(Up to 3 years.)
- Disease control rate (DCR)(Up to 3 years.)
- Progression free survival (PFS)(Up to 3 years.)
- Overall survival (OS)(Up to 3 years.)
研究者
研究点 (4)
Loading locations...
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