NCT06123494招募中3 期
A Phase 3, Multicenter, Randomized, Open-label Study of SHR-A1811 (HER2-ADC) Compared With the Chemotherapy Treatment Chosen by the Investigators for Subjects With HER2-positive Metastatic and/or Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Who Have Progressed on or After First-line Anti-HER2 Therapy-containing Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+) gastric or GEJ adenocarcinoma (based on [American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.
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, male and female;
- •Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, and unresectable locally advanced or metastatic disease
- •Prior anti-HER-2 containing treatment
- •Progression on or after first-line standard treatment (Prior neoadjuvant or adjuvant therapy can be counted as a line of therapy if the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy);
- •Centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy
- •At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);
- •Expected survival ≥12 weeks;
- •Good blood reserve and liver, kidney and coagulation function;
- •Willing to provide informed consent for study participation.
排除标准
- •Receive the last dose of anti-cancer therapy(including chemotherapy, radiotherapy, biological therapy, targeted therapy or immunotherapy) within 4 weeks, prior to the first dose;
- •Known allergies to monoclonal antibodies and inactive ingredients of this product, and allergies to paclitaxel, docetaxel, and irinotecan concurrently;
- •The toxicity of prior anti-tumor therapy did not recover to the level specified by CTCAE v5.0 grade evaluation ≤ Grade 1 or inclusion/exclusion criteria;
- •Clinically active central nervous system metastases;
- •Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •Clinically significant gastrointestinal disorder by the opinion of Investigator;
- •Has a history of immunodeficiency, including a positive HIV test;
- •During the screening visits and before the first dose, unexplained fever > 38.5℃, severe infection (CTC-AE > Grade 2), and active pulmonary inflammation were indicated by screening imaging;
- •Subjects with interstitial pneumonia or with ≥ grade 3 interstitial pneumonia during prior treatment with immune checkpoint inhibitors;
- •Active hepatitis B(HBV DNA ≥ 500 IU/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA above the lower limit of detection of the analytical method);
- •Clinically significant cardiovascular disease ,such as severe/unstable angina, symptomatic congestive heart failure (NYHA ≥ Class II.), clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, myocardial infarction within 6 months before the first dose, cerebrovascular accident (including transient ischemic attack); QTcF of 12-lead ECG was ≥470 ms; Left ventricular ejection fraction <50%; Clinically uncontrolled hypertension;
- •Had other malignancies with 5 years;
- •Pregnant or lactating women;
- •Other factors that might have led to drop out the study by the investigator opinion.
研究组 & 干预措施
SHR-A1811
Experimental
干预措施: SHR-A1811 (Drug)
The investigators' choice
Active Comparator
干预措施: Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Time from date of randomization until death (due to any cause), up to approximately 42 months
defined as the time from date of randomization until death from any cause.
次要结局
- Progression-free survival (PFS)(Time from date of randomization until first objective radiographic disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months)
- Immunogenicity indicators of SHR-A1811: including anti-SHR-A1811 antibodies (ADA and neutralizing antibodies)(approximately 42 months)
- Serum concentrations of SHR-A1811 toxin-binding antibodies and free toxin SHR169265(approximately 42 months)
- Objective response rate (ORR)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- Duration of response (DoR)(Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months)
- Disease control rate (DCR)(From start of treatment to date of documented disease progression, up to approximately 42 months)
- AE and SAE(From time subjects signs informed consent form up to 40 days after last study dose)
研究者
研究点 (1)
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