Status:
RECRUITING
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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+/...
Eligibility Criteria
Inclusion
- 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);
- ECOG: 0-1;
- Expected survival ≥12 weeks;
- Good blood reserve and liver, kidney and coagulation function;
- Willing to provide informed consent for study participation.
Exclusion
- 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.
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06123494
Start Date
January 9 2024
End Date
June 30 2027
Last Update
January 16 2024
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200433