Back to resultsA Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric
Primary Purpose
Adenocarcinoma - GEJ, Adenocarcinoma of the Stomach
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HER2 Tumor Vaccine
HER2 Tumor Vaccine+ Standard of Care chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma - GEJ
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.
Sites / Locations
- First Affiliated Hospital Bengbu Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HER2 Vaccine alone
HER2 Vaccine plus Standard of Care Chemotherapy
Arm Description
0.6 μg HER2 Vaccine
0.6 μg HER2 Vaccine plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or other Standard of Care Chemotherapy
Outcomes
Primary Outcome Measures
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Secondary Outcome Measures
To evaluate the antitumor activity
To assess per RECIST and iRECIST
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.
Full Information
NCT ID
NCT05315830
First Posted
March 30, 2022
Last Updated
April 6, 2022
Sponsor
First Affiliated Hospital Bengbu Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05315830
Brief Title
A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital Bengbu Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma - GEJ, Adenocarcinoma of the Stomach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HER2 Vaccine alone
Arm Type
Experimental
Arm Description
0.6 μg HER2 Vaccine
Arm Title
HER2 Vaccine plus Standard of Care Chemotherapy
Arm Type
Experimental
Arm Description
0.6 μg HER2 Vaccine plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or other Standard of Care Chemotherapy
Intervention Type
Biological
Intervention Name(s)
HER2 Tumor Vaccine
Intervention Description
B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28
Intervention Type
Biological
Intervention Name(s)
HER2 Tumor Vaccine+ Standard of Care chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Graded according to the NCI CTCAE version 5.0.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
To evaluate the antitumor activity
Description
To assess per RECIST and iRECIST
Time Frame
Up to 2 years
Title
Humoral and cellular immunogenicity of HER2 Tumor Vaccine
Description
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.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Zhou, MD
Phone
+86 13665527160
Email
zhouhuanbest@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zishu Wang, MD
Organizational Affiliation
First Affiliated Hospital Bengbu Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan Zhou
Phone
13665527160
12. IPD Sharing Statement
Learn more about this trial
A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric
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