NCT05278832Unknown1 期
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Dose limiting toxicities(DLTs)
研究概览
简要总结
This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.
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
- •Written informed consent.
- •Female or male.
- •ECOG performance status score 0 or
- •Histologically or cytologically confirmed diagnosis of advanced solid tumors.
- •Adequate haematological, hepatic and renal function.
排除标准
- •Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
- •Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- •Patients with a history of monoclonal antibody allergic reaction.
- •Known human immunodeficiency virus infection or known symptomatic hepatitis.
研究组 & 干预措施
QLS31905
Experimental
QLS31905 injection
干预措施: QLS31905 (Drug)
结局指标
主要结局
Dose limiting toxicities(DLTs)
时间窗: 2 years
Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905
Maximum tolerated Dose(MTD)
时间窗: 2 years
To evaluate the safety and tolerability of QLS31905
次要结局
- Progression-free Survival (PFS)(2 years)
- Objective response rate (ORR)(2 years)
- Disease control rate (DCR)(2 years)
- adverse events (AE)(2 years)
- Cmax(2 years)
- AUC(2 years)
研究者
研究点 (1)
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