OncoMatch/Clinical Trials/NCT05232916
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Is NCT05232916 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies GLSI-100 for breast cancer.
Treatment: GLSI-100 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2/neu positive primary breast cancer
Disease stage
Required: Stage I, II, III
Excluded: Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: trastuzumab-based therapy (trastuzumab) — neoadjuvant and adjuvant
Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope - Cancer Center Phoenix · Goodyear, Arizona
- Tucson Medical Center HealthCare - Tucson-Rudasill · Tucson, Arizona
- City of Hope - Duarte Cancer Center · Duarte, California
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center · Fullerton, California
- City of Hope - Orange County Lennar Foundation Cancer Center · Irvine, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05232916 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received trastuzumab-based therapy.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages