GLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer
Journal
Future oncology (London, England)
Journal Volume
18
Journal Issue
34
Date Issued
2022-10-21
Author(s)
Rugo, Hope S
Cortes, Javier
Barrios, Carlos H
Cabrera, Paula
Xu, Binghe
Kim, Sung-Bae
Melisko, Michelle
Nanda, Rita
Pieńkowski, Tadeusz
Rapoport, Bernardo L
Schwab, Richard
Abstract
Triple-negative breast cancer (TNBC) has the highest rate of distant metastasis and poorest overall survival among breast cancer subtypes. In a phase II study, adagloxad simolenin (AdaSim), a synthetic Globo H conjugate vaccine administered with adjuvant OBI-821, was shown to induce IgM and IgG anti-Globo H humoral responses in patients with metastatic breast cancer overexpressing the glycosphingolipid Globo H. GLORIA is an ongoing phase III, randomized, open-label clinical trial to evaluate the safety and efficacy of AdaSim and the quality of life (QoL) of patients receiving AdaSim plus standard of care (SOC) versus SOC alone in high-risk, early-stage TNBC. The primary end point is invasive progression-free survival; secondary end points include overall survival, QoL, breast cancer-free interval, distant disease-free survival, safety, and tolerability.
Subjects
GLORIA
Globo H
adagloxad simolenin
clinical trial
triple-negative breast cancer
vaccine
Type
review