NCT06658353招募中3 期
Single-arm, Open, Multi-center Phase III Clinical Study to Assess the Safety and Effectiveness of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This Study is a single arm, open label, multicenter phase III clinical trial to evaluate the safety and efficacy of VC004 in patients with locally advanced/metastatic solid tumors.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects or legal representatives are willing and able to sign ICF approved by the ethics committee before starting any screening procedures；
- •Male or female, age ≥12 years old;
排除标准
- •Patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures);
- •Adverse reactions caused by previous treatment have not recovered to ≤1 grade (evaluated by the investigator);
- •Patients had been treated with a strong CYP3A inhibitor or inducer within 7 days prior to the first administration of the study drug.
研究组 & 干预措施
VC004 Capsules
Experimental
干预措施: VC004 Capsules (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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