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

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.

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of the Stomach; Adenocarcinoma - GEJ
• Intervention / Treatment: Biological: HER2 Tumor Vaccine; Biological: HER2 Tumor Vaccine+ Standard of Care chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huan Zhou, MD; Phone Number: +86 13665527160; Email: zhouhuanbest@163.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233030
      • Recruiting
      • First Affiliated Hospital Bengbu Medical College
      • Contact: Huan Zhou; Phone Number: 13665527160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged ≥ 18 years;
• Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection;
• HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization [FISH];
• ECOG score of 0 ~ 2;
• Adequate bone marrow, hepatic and renal and coagulation function;
• Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
• Voluntarily participated in this study, signed the informed；

Exclusion Criteria:

• Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease；
• Subjects who have had major surgery within 4 weeks before HER2 tumor vaccine administration
• Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 5 elimination half-life prior first dose of HER2 tumor vaccine treatment;
• Subjects with known brain metastasis and/or clinically history tumor brain of metastasis；
• Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion;
• Active infection requiring treatment. HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication
• Other conditions that the investigator assessed as ineligible for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HER2 Vaccine alone; 0.6 μg HER2 Vaccine	Biological: HER2 Tumor Vaccine; B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28
Experimental: HER2 Vaccine plus Standard of Care Chemotherapy; 0.6 μg HER2 Vaccine plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or other Standard of Care Chemotherapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Graded according to the NCI CTCAE version 5.0.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the antitumor activity	To assess per RECIST and iRECIST	Up to 2 years
Humoral and cellular immunogenicity of HER2 Tumor Vaccine	Values and changes from randomization in humoral and cellular immunogenicity data including P467-specific antibodies (IgG), Her-2-specific antibodies (IgG), vaccine-specific cytokine levels and regulatory and effector T and B cells.	Up to 6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Bengbu Medical College
• Investigators: Principal Investigator: Zishu Wang, MD, First Affiliated Hospital Bengbu Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: LWY22003CBY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No