NCT05162469已完成1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- MTD of SHR-1909
研究概览
简要总结
This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;
- •Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);
- •Adequate organ function.
排除标准
- •With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion;
- •Received prior CAR T-cell therapy;
- •Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;
- •With active infection or fever of unknown origin (> 38.5 °C).
研究组 & 干预措施
SHR-1909 monotherapy
Experimental
干预措施: SHR-1909 injection (Drug)
结局指标
主要结局
MTD of SHR-1909
时间窗: From Day 1 to 4 weeks
Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)
RP2D of SHR-1909
时间窗: From Day 1 to 90 days after last dose
Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.
次要结局
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- Objective Response Rate (ORR)(Up to approximately 2 years)
- Adverse Events(90 days after the last dose)
研究者
研究点 (1)
Loading locations...
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