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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06123494•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
•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;
+3 more criteria

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 9, 2024

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

January 16, 2024

Enrollment

360

ESTIMATED participants

Conditions

HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Interventions

SHR-A1811

DRUG

Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan

DRUG

Contacts

Yang Wu

CONTACT

0518-82342973 yang.wu.yw96@hengrui.com