SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Ade
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) C
| Condition(s) | HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2024-01-09 |
| NCT ID | NCT06123494 |
| Official listing | https://clinicaltrials.gov/study/NCT06123494 |