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
Jiangsu HengRui Medicine Co., Ltd.
360 participants
Jan 9, 2024
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
SHR-A1811 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
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.
Locations(1)
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NCT06123494