Clinical Trial

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 Trastuzumab-based Therapy (FLAMINGO-01)

MOA: GLSI-100 is the individual administration of GP2, a nine amino acid peptide of the HER2/neu protein, and GM-CSF. GLSI-100 induces a CD8+ T cell response targeted to HER2- positive cells

Key Eligibility Criteria:

• Histologically confirmed HER2+ primary BC
• HLA-A02 positive, unless being enrolled in non-HLA-A02 arm
• Stage I, II, or III at presentation with residual disease at surgery or
  Stage III at presentation with pCR at surgery
• Completion of primary standard of care BC therapy
• Neoadjuvant systemic treatment consisting of at least 6 cycles of
  chemotherapy with total duration of at least 16 weeks
• Must include 9 weeks of trastuzumab (or approved biosimilar) and
  taxane based chemo – finished within one year of starting study
• Surgery
• At least 90% of planned trastuzumab-based (or approved biosimilar)
  treatment post-surgery
• Patients may continue hormone-based therapy but must not be
  receiving chemotherapy. Concurrent neratinib is prohibited.
• No clinical evidence of residual BC; Stage IV disease excluded