Phase I Immunotherapy Trial with Two Chimeric HER-2 B-Cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-MDP Adjuvant in Patients with Advanced Solid Tumors

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Tanios S Bekaii-SaabPravin T P Kaumaya

Abstract

This first-in-human phase I study (NCT01417546) evaluated the safety profile, optimal immunologic/biological dose (OID/OBD), and immunogenicity of the combination of two peptide B-cell epitope vaccines engineered to represent the trastuzumab- and pertuzumab-binding sites. Although trastuzumab and pertuzumab have been approved for clinical use, patients often develop resistance to these therapies. We have advanced a new paradigm in immunotherapy that focuses on humoral responses based on conformational B-cell epitope vaccines. The vaccine is comprised of two chimeric HER-2 B-cell peptide vaccines incorporating a "promiscuous T-cell epitope." Patients were immunized with the vaccine constructs emulsified with nor-muramyl-dipeptide adjuvant in a water-in-oil Montanide ISA 720VG vehicle. Eligible patients with metastatic and/or recurrent solid tumors received three inoculations every 3 weeks. Forty-nine patients with a median of 4 prior lines of chemotherapy received at least 1 vaccination. Twenty-eight patients completed the 3 vaccination regimens. Six patients received 1 six-month boost after the regimen, and one patient received 7 six-month boosts. No serious adverse reactions or dose-limiting toxicities were observed. The vacci...Continue Reading

Associated Clinical Trials

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Citations

Dec 6, 2019·Chemical Reviews·Ryan J MalonisOlivia Vergnolle
Jan 21, 2021·International Journal of Molecular Sciences·Sandeep PallerlaSeetharama Jois
May 25, 2021·Frontiers in Immunology·Isabella LurjeLinda Hammerich
Jun 18, 2021·Biomarker Research·Wenyu CaoQing Zhang
Aug 23, 2021·Translational Oncology·Hester A DoyleMark J Mamula

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