Phase Ib/2 Clinical Trial details (commenced and recruiting)
Name of Trial: A Study of IMU-131 Plus Standard of Care Chemotherapy in Patients with HER2/Neu Overexpressing Advanced Cancer of the Stomach.
Primary endpoints: Safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131.
Blinding status: Open label
Treatment method: 3 arms of low, mid and high dose of IMU-131 (10μg / 30μg / 50μg) plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine.
Standard of care Chemotherapy to include: Cisplatin IV on day 14, then every 21 days.
Either 5-FU administered per day as continuous infusion for 96 hours on days 14, 17 and then every 21 days or Capecitabine for 14 days orally (twice daily) on days 14 to 27, then every 21 days.
Number of trial subjects: 18 (Phase 1b), followed by 68 (Phase 2).
Control group: Standard of care drugs: Cisplatin and either Fluorouracil (5-FU) or Capecitabine.
Selection criteria: Patients with metastatic gastric of GEJ adenocarcinoma aged over 20 years with no prior chemotherapy or radiotherapy for advanced gastric cancer within 6 months. Full criteria via link below.
Trial locations: 8 trial locations in Hong Kong, Thailand and Taiwan.
Dr Thomas Yau (Hong Kong), Dr Wirote Lausoontornsiri, Dr Arunee Dechauphunkul, Dr Jedzada Maneechavakajorn, Dr Suebpong Tansanvimon, Dr Chaiyut Charoentum (Thailand), Dr Yee Chao, Dr Chia-Jui Yen (Taiwan)
Expected duration: Phase 1b – 12 months
Full trial details are available via the link below under the identifier number: NCT02795988
Link: https://clinicaltrials.gov/show/NCT02795988 (RECRUITING)
Previous Phase I
HER-Vaxx has previously completed a Phase I clinical trial with ten HER-2 positive patients with metastatic breast cancer. The results showed that HER-Vaxx was safe, well tolerated and effective in overcoming immunological tolerance to HER-2.
The results of this trial have been published:
Wiedermann U, C. Wiltschke, J. Jasinska, M. Kundi, R. Zurbriggen, E. Garner-Spitzer. R. Bartsch, G. Steger, H. Pehamberger, O. Scheiner, C.C. Zielinski. 2010. A virosomal formulated HER-2/neu multi-peptide vaccine induces HER2/neu specific immune responses in patients with metastatic breast cancer: a phase I study. Breast Cancer Res Treat. 119(3):673-83.