Open AccessGLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer
Author(s) -
Hope S. Rugo,
Javier Cortés,
Carlos H. Barrios,
Paula Cabrera,
Binghe Xu,
ChiunSheng Huang,
SungBae Kim,
Michelle Melisko,
Rita Nanda,
Tadeusz Pieńkowski,
Bernardo Leon Rapoport,
Richard B. Schwab
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2022-0812
Subject(s) - medicine , triple negative breast cancer , breast cancer , oncology , tolerability , adjuvant , clinical endpoint , cancer , clinical trial , adverse effect
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.