Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-06.
Status change: Not Yet Recruiting → Recruiting 2024-01-11
Trial Details
NCT Number NCT06123494
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Enrollment 360 participants
Start Date 2024-01-09
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-01-16