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GLSI-100 · 1 trial · 1 indication
IBCFS is defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality (STEEP version 2).
| Arm | Type | Description |
|---|---|---|
| 0.9% Normal Saline | PLACEBO_COMPARATOR | 0.9% normal saline in subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
| GLSI-100 | EXPERIMENTAL | GLSI-100 immunotherapy in subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
| GLSI-100, Open-label | EXPERIMENTAL | Open-label arm: GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | 0.9% Normal Saline |
| GLSI-100 | BIOLOGICAL | 500 mcg/mL GP2 and 125 mcg/mL GM-CSF |
Inclusion Criteria: * Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied at diagnosis (multifocal, multicentric, or synchronous contralateral disease) * Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer th...
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GLSI-100 is an investigational immunotherapy being developed for HER2/neu positive breast cancer. It is designed for patients with HER2-positive disease and is being studied in a Phase 3 clinical trial to evaluate its efficacy and safety in this population.
GLSI-100 targets HER2/neu, a protein overexpressed in certain breast cancers. The therapy combines a HER2/neu peptide (GP2) with GM-CSF, an immune stimulant, to elicit an immune response against HER2-positive tumor cells.
GLSI-100 is being developed by Greenwich LifeSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker GLSI. The company is focused on advancing this investigational therapy for HER2-positive breast cancer.
GLSI-100 is in Phase 3 clinical development. The ongoing trial is a randomized, double-blind, placebo-controlled study, and the U.S. Food and Drug Administration has granted it Fast Track designation for the treatment of HER2-positive breast cancer.
GLSI-100 is being evaluated in a Phase 3 trial, NCT05232916, titled 'Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects.' The trial is currently recruiting and plans to enroll 2,250 participants across multiple countries.