{"entity":{"id":"glsi-100","kind":"drug","name":"GLSI-100","aka":[],"tldr":"GLSI-100 is an experimental cancer vaccine from Greenwich LifeSciences in phase 3 trials for HR-positive / HER2-negative breast cancer, aimed at HER2.","summary":"GLSI-100 is a cancer vaccine developed by Greenwich LifeSciences. Its target is HER2 (the sponsor names HER2/neu). The sponsor states: Combines GP2, a nine-amino-acid HER2/neu-derived transmembrane peptide, with the immunoadjuvant GM-CSF to prime and expand HER2/neu-specific CD8+ cytotoxic T lymphocytes that recognise and destroy HER2/neu-expressing cancer cells, aiming to prevent breast cancer recurrence. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT05232916 (Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects), in HR-positive / HER2-negative breast cancer. The largest, NCT05232916, plans to enrol 2250 participants with primary completion expected 2031-12. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of GLSI-100","url":"https://clinicaltrials.gov/search?intr=GLSI-100"},{"label":"Sponsor pipeline page","url":"https://greenwichlifesciences.com/gp2/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["greenwich-lifesciences"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05232916"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"vaccine","mechanism":"Combines GP2, a nine-amino-acid HER2/neu-derived transmembrane peptide, with the immunoadjuvant GM-CSF to prime and expand HER2/neu-specific CD8+ cytotoxic T lymphocytes that recognise and destroy HER2/neu-expressing cancer cells, aiming to prevent breast cancer recurrence.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/glsi-100/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"greenwich-lifesciences","kind":"company","name":"Greenwich LifeSciences","route":"/companies/greenwich-lifesciences/"}],"trial":[{"id":"nct05232916","kind":"trial","name":"Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects","route":"/trials/nct05232916/"}]}}