Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05232916
Trial Phases:	Phase III	Protocol IDs:	GLSI-21-01 (primary) NCI-2022-03768
Eligibility:	18 - 100 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Greenwich LifeSciences, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05232916

Summary

This is a prospective, randomized, double-blinded, placebo-controlled, multi-center,
Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive
subjects who are at high risk for disease recurrence and have completed both neoadjuvant
and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal
injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5
booster intradermal injections spaced 6 months apart. A third open-label arm will explore
GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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