Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Breast Cancer
Unknown Primary
18 - 100 Years, Male and Female
GLSI-21-01 (primary)
NCI-2022-03768
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.
Eligibility
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous contralateral disease)
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy
- The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
- Subject must both reside in and have been treated for their cancer in the country in which the clinical site is located.
Treatment Sites in Georgia
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