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

NCT ID: NCT05315830

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2024-03-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HER2 Vaccine alone

0.6 μg HER2 Vaccine

Group Type: EXPERIMENTAL

HER2 Tumor Vaccine

Intervention Type: BIOLOGICAL

B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28

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

Group Type: EXPERIMENTAL

HER2 Tumor Vaccine+ Standard of Care chemotherapy

Intervention Type: BIOLOGICAL

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

Interventions

HER2 Tumor Vaccine

B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28

Intervention Type: 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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wang Zishu

MD，Head of Oncology Department, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zishu Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Bengbu Medical University

Locations

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huan Zhou, MD

Role: CONTACT

zhouhuanbest@163.com

+86 13665527160

Facility Contacts

Huan Zhou

Role: primary

13665527160

Other Identifiers

LWY22003CBY

Identifier Type: -

Identifier Source: org_study_id