NCT05315830

A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric

A Single-Arm, Open-Label, Exploratory Study to Evaluate the Safety of HER2 Tumor Vaccine Injection Alone/in Combination With Standard of Care Chemotherapy in Patients With her2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The First Affiliated Hospital of Bengbu Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, clinical study to evaluate the safety of HER2 tumor vaccine injection alone/in combination with standard of care chemotherapy in patients with HER2/neu overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of HER2 tumor vaccine.

Conditions

• Adenocarcinoma - GEJ
• Adenocarcinoma of the Stomach

Interventions

Type	Name	Description
BIOLOGICAL	HER2 Tumor Vaccine	B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28
BIOLOGICAL	HER2 Tumor Vaccine+ Standard of Care chemotherapy	B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28 Standard of Care Chemotherapy cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle) or other standard of care chemotherapy

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-03-01
• Completion: 2024-03-01
• First posted: 2022-04-07
• Last updated: 2022-04-14

Locations

1 site across 1 country: China