NCT06434597招募中2 期
A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
- •HER2 positive or HER2 gene mutation;
- •Meet the requirements of previous treatment;
- •ECOG performance status of 0 or 1；
- •Expected survival ≥ 3 months;
- •No serious abnormalities in hematopoietic function, liver or kidney function;
- •Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
- •Fully informed subjects who voluntarily sign the ICF.
排除标准
- •Subjects who have previously received anti-HER2 molecular targeted therapy;
- •Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
- •Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease;
- •Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;
- •5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation;
- •Other situations that do not meet the requirements of the protolol.
研究组 & 干预措施
SPH5030
Experimental
干预措施: SPH5030 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
次要结局
- Duration of remission (DOR)(Approximately 2 years)
- Disease control rate (DCR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)
- Overall Survival (OS)(Approximately 2 years)
- Incidence of Treatment-Emergent Adverse Events(Approximately 2 years)
研究者
研究点 (30)
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