NCT04111445终止1 期
First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Adagene Inc
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of participants experiencing dose-limiting toxicities
研究概览
简要总结
This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant or nursing females.
- •Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
- •Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
- •Any active autoimmune disease or documented history of autoimmune disease.
- •Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
- •Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade
- •History of clinically significant cardiac disease.
- •Uncontrolled current illness.
研究组 & 干预措施
ADG116
Experimental
干预措施: ADG116 (Drug)
结局指标
主要结局
Number of participants experiencing dose-limiting toxicities
时间窗: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Number of participants experiencing clinical and laboratory adverse events (AEs)
时间窗: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
次要结局
未报告次要终点
研究者
研究点 (1)
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