NCT07815002尚未招募1 期
Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of 3SC009 Monotherapy for Patients 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
- 尚未招募
- 入组人数
- 100
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This study includes two parts, different part has different administration frequencies of 3SC009.
详细描述
3SC009 is a bispecific antibody targeting EpCAM and CD47. This study is a study of 3SC009 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of 3SC009. The first Part is Q2W and Second part is QW. Each part will assess the efficacy and safety of the preset several dose levels of 3SC009 in 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
- •Males and/or females over age 18
- •Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >=3 months.
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease.
- •Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.6.0).
- •Inadequate organ or bone marrow function.
- •Pregnant or breast-feeding woman.
- •Known allergies, hypersensitivity, or intolerance to 3SC009 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
different doses of 3SC009
Experimental
different dose levels of 3SC009
干预措施: 3SC009 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: From the first dose of 3SC009 until 28 days after last dose of 3SC009
Number of participants with DLTs
时间窗: At the end of Cycle 1 (up to 14 days)
次要结局
- The blood concentration of 3SC009(From first dose of 3SC009 through 28 days after last dose of 3SC009)
- The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)(From first dose of 3SC009 through 28 days after last dose of 3SC009)
- Objective response rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
研究者
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