OncoMatch/Clinical Trials/NCT06414733
HER-2 B Cell Peptide Vaccine
Is NCT06414733 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 for metastatic breast cancer.
Treatment: Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 — This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 1+, 2+, or 3+) (IHC 1+, 2+, or 3+)
HER-2 (IHC 1+, 2+ and 3+)...to be enrolled on this study
Required: HER2 (ERBB2) amplification
HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC)...
Required: EGFR overexpression
EGFR over-expression (FISH and IHC)
Required: EGFR amplification
EGFR over-expression (FISH and IHC)
Required: HER2 (ERBB2) wild-type (IHC 0 AND FISH negative)
Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO/CAP guidelines
Required: EGFR wild-type (under-expressing EGFR based on FISH and IHC)
or are under-expressing EGFR based on FISH and IHC
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard systemic therapy — metastatic
must have received or refused first line standard systemic therapy for their metastases (if applicable)
Cannot have received: CDK4/6 inhibitor
Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6...inhibitors in combination with endocrine therapy
Cannot have received: mTOR inhibitor
Patients on targeted therapies, such as...mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy
Lab requirements
Blood counts
ANC ≥ 1,000/mm³, platelet count > 700,000/mm³
Kidney function
Creatinine <1.5 mg/dl or calculated creatinine clearance > 60 ml/min
Liver function
Serum bilirubin < 1.5 mg%, ALT must be < 2 times upper limit of normal
Cardiac function
Left ventricular ejection fraction within normal limits (or 50% or higher) by Echocardiogram or MUGA
ANC ≥ 1,000/mm³, platelet count > 700,000/mm³. Serum bilirubin < 1.5 mg%, ALT must be < 2 times upper limit of normal. Creatinine <1.5 mg/dl or calculated creatinine clearance > 60 ml/min. Echocardiogram or MUGA and require the left ventricular ejection fraction to be within normal limits (or 50% or higher).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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