NCT07051486招募中2 期
A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment
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
- 2
- 主要终点
- Objective response rate (ORR) assessed by Independent Review Committee (IRC)
研究概览
简要总结
This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
- •Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
- •Cervical cancer confirmed by tissue or cytological pathology.
- •Expected survival ≥ 12 weeks.
- •Normal function of important organs.
- •Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months.
排除标准
- •Subjects with known untreated or active central nervous system (CNS) tumor metastases.
- •Subjects with other malignant tumors in the past or at the same time.
- •Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
- •Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- •Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
- •Subjects with known lung damage caused by concurrent lung diseases.
- •Subjects with active pulmonary tuberculosis.
- •Subjects with poorly controlled or severe cardiovascular diseases.
- •Subjects with arterial/venous thrombotic events within 1 month before enrollment.
- •Subjects who had a serious infection within 1 month before enrollment.
- •History of immunodeficiency, including positive HIV test.
研究组 & 干预措施
SHR-A1811 Group
Experimental
干预措施: SHR-A1811 Injection (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
时间窗: Up to 2 years.
次要结局
- Adverse events (AEs)(Up to 2 years.)
- Duration of response (DoR) assessed by Independent Review Committee (IRC)(Up to 2 years.)
- Serious adverse events (SAEs)(Up to 2 years.)
- Disease control rate (DCR) assessed by Independent Review Committee (IRC)(Up to 2 years.)
- Overall survival (OS) assessed by Independent Review Committee (IRC)(Up to 2 years.)
- Overall survival (OS) assessed by investigators(Up to 2 years.)
- Progression free survival (PFS) assessed by Independent Review Committee (IRC)(Up to 2 years.)
- Progression free survival (PFS) assessed by investigators(Up to 2 years.)
- Duration of response (DoR) assessed by investigators(Up to 2 years.)
- Disease control rate (DCR) assessed by investigators(Up to 2 years.)
- Objective response rate (ORR) assessed by investigators(Up to 2 years.)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer PatientsHER2-positive Breast CancerNCT05635487Shengjing Hospital65
招募中
2 期
A Study of SHR-A1811 in Subjects With Gynaecologic OncologyGynaecological MalignanciesNCT05896020Jiangsu HengRui Medicine Co., Ltd.225
已完成
1 期
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast CancerAdvanced Breast CancerNCT06710990Jiangsu HengRui Medicine Co., Ltd.17
已完成
2 期
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)Extranodal Natural Killer/T-Cell LymphomaNCT03595657CStone Pharmaceuticals80
已完成
2 期
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin LymphomaHodgkin LymphomaNCT03505996CStone Pharmaceuticals82