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

NCT05315830 | Unknown Phase 1

• 1 other identifier: LWY22003CBY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Graded according to the NCI CTCAE version 5.0.

  Up to 6 months

Secondary Outcomes (2)

• To evaluate the antitumor activity

  Up to 2 years

• Humoral and cellular immunogenicity of HER2 Tumor Vaccine

  Up to 6 months

Study Arms (2)

HER2 Vaccine alone

EXPERIMENTAL

0.6 μg HER2 Vaccine

Biological: HER2 Tumor Vaccine

HER2 Vaccine plus Standard of Care Chemotherapy

EXPERIMENTAL

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

Interventions

HER2 Tumor Vaccine BIOLOGICAL

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

HER2 Vaccine alone

HER2 Tumor Vaccine+ Standard of Care chemotherapy 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

HER2 Vaccine plus Standard of Care Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University: lead

Study Sites (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, 233030, China

RECRUITING

Study Officials

• Zishu Wang, MD

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Zhou, MD

CONTACT

+86 13665527160; zhouhuanbest@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，Head of Oncology Department, Principal Investigator

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: March 7, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 14, 2022

Record last verified: 2022-03

Locations

CN (1)