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IMU-131

BIOLOGICAL2 trials

Sponsors

Imugene Limited

Conditions

AdenocarcinomaCancer of StomachGastric AdenocarcinomaGastric CancerGastroesophageal Junction AdenocarcinomaGastrointestinal NeoplasmsStomach AdenocarcinomaStomach Cancer

Phase 1

A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
CompletedNCT02795988
Imugene LimitedAdenocarcinoma, Gastrointestinal Neoplasms
Start: 2017-08-30End: 2024-03-20Updated: 2025-04-16

Phase 2

A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
TerminatedNCT05311176
Imugene LimitedCancer of Stomach, Gastric Adenocarcinoma, Gastric Cancer +3
Start: 2022-08-17End: 2024-04-04Updated: 2025-05-11

Related Papers

Abstract P1-07-15: Tumor size reduction and overall survival improvement in HER2-overexpressing cancer patients vaccinated with HER-Vaxx, a B-cell peptide-based vaccine, plus standard-of-care chemotherapy
Clinical Cancer Research2025-06-131 citations
Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON)
Clinical Cancer Research2024-07-1919 citations
Abstract CT215: Frontline vaccination with the B-cell peptide compound HER-Vaxx (IMU-131), combined with standard-of-care chemotherapy induces high levels of HER2-specific antibodies mediating ADCC and intracellular phosphorylation inhibition resulting in overall survival benefit in patients with HER2+ metastatic or advanced gastric/GEJ adenocarcinoma - Final results from Phase II/HERIZON study
Cancer Research2024-04-051 citations
HERIZON: A phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine, plus standard of care chemotherapy in patients with HER2-overexpressing metastatic or advanced gastric/GEJ adenocarcinoma— Overall survival analysis.
Journal of Clinical Oncology2023-01-2412 citations
nextHERIZON: A phase 2 study of HER-Vaxx, a HER2-targeting peptide vaccine, in combination with chemotherapy or pembrolizumab in patients with HER2 metastatic or advanced gastric/gastroesophageal adenocarcinoma that progressed on or after trastuzumab treatment.
Journal of Clinical Oncology2023-01-242 citations
Abstract CT107: A PHASE 1B/2 OPEN-LABEL STUDY WITH RANDOMIZATION IN PHASE 2 OF IMU-131 HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION
Cancer Research2021-07-014 citations
HERIZON: A phase 1B/2 open-label study of imu-131 HER2/neu peptide vaccine PLUS standard of care chemotherapy with randomization in phase 2 in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.
Journal of Clinical Oncology2021-05-204 citations
Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer—Results from Phase Ib Trial IMU.ACS.001
Clinical Cancer Research2021-04-2040 citations
A phase Ib study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.
Journal of Clinical Oncology2019-05-203 citations
A phase Ib/II open label study of IMU-131 HER2/Neu peptide vaccine plus cisplatin and either 5-fluorouracil or capecitabine chemotherapy in patients with HER2/Neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.
Journal of Clinical Oncology2019-01-292 citations