drugset / Trial / NCT05315830
A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2022-03-07
- Primary completion
- 2023-03-01
- Completion
- 2024-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HER2 Tumor Vaccine | Vaccine | 0.6 ug | Intramuscular |
| Background | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Background | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 4000 mg/m2 | Other |