NCT04233060已完成1 期
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 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
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with Advanced 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
- 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
- •Has disease that is suitable for local treatment administered with curative intent
- •Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- •Patients with any condition that impairs their ability to take oral medication.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Subjects with active, known, or suspected autoimmune disease in the past 3 years prior to the start of treatment.
- •History of active tuberculosis, both pulmonary and extrapulmonary.
- •Clinically Significant history of cardiac disease within 6 months prior to 1st dosing, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication.
- •Subjects with ascites, pleural effusion, pericardial effusion which cannot be reversed by appropriate interventions.
- •Subjects with any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment.
- •Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- •History of organ transplant that requires the use of immunosuppressive treatment.
- •For post immunotherapy patients, with prior ≥ Grade 3, serious, or life-threatening immune-mediated reactions following prior anti-PD-(L)1 or other immune-oncology therapies.
- •Subjects who have received systemic anti-tumor treatments 21 days prior to the initiation of the study treatment.
- •Subjects who have received treatment with approved anti-tumor Chinese herbal medicine or Chinese prepared.
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
- •Has received treatment with non-selective adenosine antagonist or A2a receptor antagonist.
- •Concurrent administration of strong inhibitors or inducers of CYP3A4 and CYP1A2 is not permitted
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
研究组 & 干预措施
CS3005
Experimental
干预措施: CS3005 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From the day of first dose to 30 days (±7 days) after last dose of CS3005, 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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