Adenocarcinoma - GEJPhase 1NCT05315830
A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric
A Phase 1 study testing HER2 Tumor Vaccine in people with Adenocarcinoma - GEJ and Adenocarcinoma of the Stomach, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma - GEJ, Adenocarcinoma of the Stomach
- What is being tested?
- HER2 Tumor Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2022to 1 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, 233030
Huan Zhou, 13665527160
About this study
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
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.
- Being tested
- HER2 Tumor Vaccine, HER2 Tumor Vaccine+ Standard of Care chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 Tumor VaccineBiological
B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28
HER2 Tumor Vaccine+ Standard of Care chemotherapyBiological
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
| Study group | Role | What they receive |
|---|---|---|
| HER2 Vaccine alone | Experimental | 0.6 μg HER2 Vaccine Receives: 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 Receives: Biological: HER2 Tumor Vaccine+ Standard of Care chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Measured: Up to 6 months
Secondary outcomes (2)
To evaluate the antitumor activity
To assess per RECIST and iRECIST
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start7 Mar 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma - GEJStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zishu, The First Affiliated Hospital of Bengbu Medical University
- Investigators
- Zishu Wang, MD, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315830
- Sponsor's protocol ID
- LWY22003CBY
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05315830
- Acronym / sponsor ID
- LWY22003CBY
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 Vaccine alone | Experimental | Biological: HER2 Tumor Vaccine0.6 μg HER2 Vaccine |
| HER2 Vaccine plus Standard of Care Chemotherapy | Experimental | Biological: HER2 Tumor Vaccine+ Standard of Care chemotherapy0.6 μg HER2 Vaccine plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or other Standard of Care Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER2 Tumor VaccineB-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28 | Biological | HER2 Vaccine alone |
| HER2 Tumor Vaccine+ Standard of Care chemotherapyB-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 | Biological | HER2 Vaccine plus Standard of Care Chemotherapy |
Primary outcome
Incidence of adverse events
Time frame: Up to 6 months
Graded according to the NCI CTCAE version 5.0.
2 secondary outcomes
To evaluate the antitumor activity
Time frame: Up to 2 years
Humoral and cellular immunogenicity of HER2 Tumor Vaccine
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zishu Wang, MD principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HER2 Tumor Vaccine in people with Adenocarcinoma - GEJ and Adenocarcinoma of the Stomach, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou, MD (+86 13665527160, zhouhuanbest@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.