NCT07450976尚未招募2 期
A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR) assessed by investigator.
研究概览
简要总结
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18-75 years old (including both ends), male or female;
- •ECOG-PS score: 0 or 1;
- •Expected survival ≥ 12 weeks;
- •Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- •CLDN18.2 positive expression;
- •Subjects who failed or intolerance after systemic chemotherapies;
- •According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
- •The main organ function is normal, in line with the program requirements;
- •Consent to contraception.
排除标准
- •Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- •Other active malignancies within 5 years or at the same time;
- •Subjects with a history or evidence of brain metastasis or meningeal metastasis;
- •With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
- •Severe trauma or major surgery was performed within 4 weeks before the first administration;
- •To study the severe heart disease within 6 months before the first administration;
- •Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
- •Severe infection symptoms occurred within 2 weeks before the first administration;
- •Known hereditary or acquired bleeding and thrombotic tendency;
- •Congenital or acquired immune defects;
- •The subjects had severe and uncontrollable concomitant diseases;
- •Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.
研究组 & 干预措施
SHR-A1904 Cohort A Group
Experimental
SHR-A1904 for injection, low dose.
干预措施: SHR-A1904 for Injection (Drug)
SHR-A1904 Cohort B Group
Experimental
SHR-A1904 for injection, high dose.
干预措施: SHR-A1904 for Injection (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by investigator.
时间窗: Until progression, assessed up to approximately 1 year.
Phase IIa.
次要结局
- Disease control rate (DCR) assessed by investigator.(Approximately 1 year.)
- Duration of objective tumor response (DoR) assessed by investigator.(Approximately 1 year.)
- Time to response (TTR) assessed by investigator.(Approximately 1 year.)
- Progression-free survival (PFS) assessed by investigator.(Approximately 1 year.)
- Overall survival (OS).(Approximately 2 years.)
- Adverse events (AEs).(Until study completion, assessed up to approximately 1 year.)
- Serious adverse events (SAEs).(Until study completion, assessed up to approximately 1 year.)
- Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA).(Approximately 6 months.)
- Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb).(Approximately 6 months.)
研究者
研究点 (2)
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