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Trial Title:
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
NCT ID:
NCT06123494
Condition:
HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Paclitaxel
Docetaxel
Irinotecan
Ramucirumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
SHR-A1811 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
Arm group label:
SHR-A1811
Intervention type:
Drug
Intervention name:
Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan
Description:
Ramucirumab 8mg/kg，D 1,15 + Paclitaxel 80mg/m2，D1,8,15，Q4W; Paclitaxel
80mg/m2，D1,8,15，Q4W; Docetaxel 75mg/m2，D1，Q3W; Irinotecan 150mg/m2，D1，Q2W.
Arm group label:
The investigators' choice
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+/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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old, male and female;
2. Histologically or cytologically confirmed gastric or gastroesophageal junction
adenocarcinoma, and unresectable locally advanced or metastatic disease
3. Prior anti-HER-2 containing treatment
4. 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);
5. 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
6. At least one measurable lesion according to the solid tumor response Evaluation
Criteria (RECIST 1.1);
7. ECOG: 0-1;
8. Expected survival ≥12 weeks;
9. Good blood reserve and liver, kidney and coagulation function;
10. Willing to provide informed consent for study participation.
Exclusion Criteria:
1. 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;
2. Known allergies to monoclonal antibodies and inactive ingredients of this product,
and allergies to paclitaxel, docetaxel, and irinotecan concurrently;
3. 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;
4. Clinically active central nervous system metastases;
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated
drainage;
6. Clinically significant gastrointestinal disorder by the opinion of Investigator;
7. Has a history of immunodeficiency, including a positive HIV test;
8. 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;
9. Subjects with interstitial pneumonia or with ≥ grade 3 interstitial pneumonia during
prior treatment with immune checkpoint inhibitors;
10. 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);
11. 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;
12. Had other malignancies with 5 years;
13. Pregnant or lactating women;
14. Other factors that might have led to drop out the study by the investigator opinion.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li
Phone:
+86-21-38804518
Email:
lijin@csco.org.cn
Start date:
January 9, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123494
