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

NCT05315830 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    lead OTHER

Principal Investigators

  • Zishu Wang, MD · The First Affiliated Hospital of Bengbu Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2023-03-01
Completion
2024-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315830 on ClinicalTrials.gov