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 intradermal administration of GP2, a 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
• Stage I, II, or III at presentation with residual disease at surgery or Stage III at
  presentation with pCR at surgery
• Stage IV disease is excluded
• All HLA types are eligible. HLA screening can occur as early as surgery (blood
  test).
• Completion of primary SOC BC therapy
  • At least 6 cycles of neoadjuvant chemotherapy
    • MUST include at least 3 cycles of taxane-based chemo over 9 weeks
    • May include anthracycline-based chemo
    • At least 3 cycles of trastuzumab (or approved biosimilar) over 9 weeks
• Surgery
• Adjuvant tx with at least 90% of planned post-surgical trastuzumab-based (or
  approved biosimilar) tx
  • For residual disease at surgery, T-DM1 must be attempted as 1st tx
  • For pCR at surgery, adjuvant trastuzumab-based tx must be completed (at
    least 16 cycles total over one year)
• Pts may continue hormone-based therapy but must not be receiving
  chemotherapy. Concurrent neratinib is prohibited.