NCT05315830 is a Phase 1 clinical trial of HER2 Tumor Vaccine in Adenocarcinoma - GEJ, sponsored by The First Affiliated Hospital of Bengbu Medical University.

Who is sponsoring NCT05315830?

NCT05315830 is sponsored by The First Affiliated Hospital of Bengbu Medical University.

What drugs are being tested in NCT05315830?

Interventions in NCT05315830: HER2 Tumor Vaccine, HER2 Tumor Vaccine+ Standard of Care chemotherapy.

What condition does NCT05315830 study?

NCT05315830 studies Adenocarcinoma - GEJ, Adenocarcinoma of the Stomach.

Is NCT05315830 still recruiting?

NCT05315830 is currently status unknown. Last updated 14 April 2022.

Last reviewed 2022-04-14 · How we verify

NCT05315830

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 14 April 2022

What this trial tests

Phase 1 trial testing HER2 Tumor Vaccine in Adenocarcinoma - GEJ in 10 participants. Status unknown.

Timeline

7 March 2022

Primary endpoint
1 March 2023

1 March 2024

Quick facts

Lead sponsor	The First Affiliated Hospital of Bengbu Medical University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	7 March 2022
Primary completion	1 March 2023
Estimated completion	1 March 2024
Sites	1 location across China

Drugs / interventions tested

HER2 Tumor Vaccine — full drug profile →
HER2 Tumor Vaccine+ Standard of Care chemotherapy — full drug profile →

Conditions studied

Adenocarcinoma - GEJ — all drugs for Adenocarcinoma - GEJ →
Adenocarcinoma of the Stomach — all drugs for Adenocarcinoma of the Stomach →

Sponsor

The First Affiliated Hospital of Bengbu Medical University

Who can join

18 and older, any sex, with Adenocarcinoma - GEJ or Adenocarcinoma of the Stomach. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments.
Scheck MK, Hofheinz RD, Lorenzen S. · · 2024 · cited 28× · PMID 38611014 · DOI 10.3390/cancers16071336
Breaking barriers: Smart vaccine platforms for cancer immunomodulation.
Gomari MM, Ghantabpour T, Pourgholam N, Rostami N, et al · · 2025 · cited 5× · PMID 39901621 · DOI 10.1002/cac2.70002
Clinical Applications of Combined Immunotherapy Approaches in Gastrointestinal Cancer: A Case-Based Review.
Eralp Y, Ates U. · · 2023 · cited 2× · PMID 37896948 · DOI 10.3390/vaccines11101545
Immune, molecular and genetic profiles of gastric signet ring cell carcinoma: Recent progress and future challenges.
Wang Q, Zhou S, Fang X, He X, et al · · 2026 · PMID 41902313 · DOI 10.1002/ijc.70416

Verify or expand the search:

Other recruiting trials for Adenocarcinoma - GEJ

Currently open trials in the same condition.

NCT06059495 — Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study · Phase 2 · recruiting

Other The First Affiliated Hospital of Bengbu Medical University trials

Trials by the same sponsor.

NCT07300215 — An Exploratory Study on Individualized Neoadjuvant Treatment Regimens for Early HR+/HER2+ Breast Cancer · Phase 2 · not yet recruiting
NCT06959186 — Risk Stratification Via HF-QRS and Fibrosis Biomarkers in Heart Failure · not yet recruiting
NCT06957392 — Mechanisms and Interventions of Social Reward on Cognitive Control in Internet Gaming Disorder · NA · recruiting
NCT07330882 — Health Behavior Management Program for Patients With Coronary Heart Disease · NA · enrolling by invitation
NCT06253598 — Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenv · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05315830 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Bengbu Medical University
Last refreshed: 14 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05315830.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing