Flamingo-01
A randomized, multicenter, placebo-controlled, phase 3 study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu positive subjects with residual disease or high-risk PCR after both neoadjuvant and postoperative adjuvant trastuzumab-based therapy.
Introduction
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Study Information
Phase: III
Protocol numer: GLSI-21-01
Investigational product: GLSI-100
IND-number: 17304
NCT-number: 05232916
EU CT-number: 2023-504323-25
Sponsor:
Greenwich LifeSciences, Inc.
3992 Bluebonnet Drive, Building 14
Stafford, Texas 77477 (USA)
News
Patient recruitment has started. In Germany the first patient was recruited in mid-2024 (pre-screening for HLA status).
Primary objective
To assess the efficacy of GLSI-100 compared to placebo in HLA-A*02 positive and HER2/new positive breast cancer subjects who have a high risk of disease recurrence (stage I, II, or III at presentation with residual disease at surgery or stage III at presentation with pathologic complete response [pCR] at surgery) and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based standard of care therapy.
Study Design
The inclusion and exclusion criteria, as well as more detailed information on the study design, can be found in the Synopsis.
Contact
Viktoria Tierbach