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GLSI-100

Vaccine (Peptide vaccine) · Immune activation, directed at HER2/neu (ERBB2) · developed by Greenwich LifeSciences

Phase 3 Most advanced trial

GLSI Developer

1 Registered trials

What is GLSI-100?

GLSI-100 is a cancer peptide vaccine comprising the GP2 epitope derived from HER2/neu and the immune adjuvant GM-CSF. It is designed to induce cytotoxic T-lymphocyte-mediated immune responses against HER2/neu-expressing tumor cells. The vaccine is being studied in breast cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Drug type: Vaccine (Peptide vaccine)
Targets: HER2/neu (ERBB2) (antigen)
Mechanism: Immune activation, directed at HER2/neu (ERBB2)
Pathways: immune_activation, CTL-mediated immune response
Therapy area: Oncology
Developer: Greenwich LifeSciences, Inc. (GLSI)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 3

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05232916	Phase 3	Breast Cancer	Recruiting	GLSI

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Breast Cancer

Other drugs acting on ERBB2

Neratinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 ELVN-002 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1 TTX-MC138 Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the GLSI page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z