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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

StatusRecruiting
PhasePhase 3
Started2024-01-09
View on ClinicalTrials.gov ↗

Amendment history

2024-01-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-01→confirmed 2024-01-09
Study sites0→1
2023-11-06
Original filing
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.
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