NCT05884801招募中1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid 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
- 148
- 试验地点
- 1
- 主要终点
- Recommended dose for phase II (RP2D)
研究概览
简要总结
This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- •Aged ≥18 years old;
- •Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
- •Failure of adequate standard treatment, or no effective standard treatment;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- •Life expectancy ≥12 weeks;
排除标准
- •Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
- •Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
- •Subjects received major surgery within 4 weeks prior to the first dose;
- •Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy;
- •Cardiovascular and cerebrovascular diseases with clinical significance;
- •Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.
研究组 & 干预措施
QLS1103 Dose Escalation and Expansion
Experimental
干预措施: QLS1103 (Drug)
结局指标
主要结局
Recommended dose for phase II (RP2D)
时间窗: Up to 24 approximately months
Adverse events(AEs) / Serious adverse events(SAEs)
时间窗: Up to 24 approximately months
Maximum tolerated dose (MTD)
时间窗: 21 Days (first cycle)
次要结局
- Maximum observed plasma concentration (Cmax) of QLS1103(Up to approximately 2 years)
- Time of maximum observed plasma concentration (Tmax) of QLS1103(Up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 2 years)
- Area under the plasma concentration-time curve (AUC) of QLS1103(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Progression free survival (PFS)(Up to approximately 2 years)
研究者
研究点 (1)
Loading locations...
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