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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 monoclonal antibody being developed for breast cancer. It is currently being evaluated in a Phase 3 clinical trial for HER2/neu positive breast cancer patients. The drug is administered as a peptide vaccine combined with GM-CSF to stimulate an immune response against HER2/neu expressing tumors.
GLSI-100 targets the HER2/neu protein, which is overexpressed in certain breast cancers. It is a peptide-based immunotherapy designed to elicit an immune response against HER2/neu positive tumor cells. The drug combines the GP2 peptide with GM-CSF as an adjuvant to enhance the immune system's ability to recognize and attack cancer cells.
GLSI-100 is being developed by Greenwich LifeSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol GLSI. The company is conducting a Phase 3 clinical trial to evaluate the efficacy and safety of GLSI-100 in HER2/neu positive breast cancer patients.
GLSI-100 is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review process for serious conditions with unmet medical needs.
GLSI-100 is being studied in a Phase 3 clinical trial registered as NCT05232916. This randomized, double-blind, placebo-controlled trial is recruiting approximately 2,250 participants with HER2/neu positive breast cancer. The study is being conducted in the United States and several European countries, including Belgium, France, Germany, Ireland, Italy, Poland, Portugal, Romania, and Spain.
GLSI-100 is a combination product that includes the GP2 peptide and GM-CSF. GP2 is the HER2/neu peptide component of GLSI-100, while GM-CSF serves as an immune-stimulating adjuvant. In clinical trials, GLSI-100 is referred to as GP2 plus GM-CSF, and the study title specifically mentions GLSI-100 (GP2 + GM-CSF).