OncoMatch/Clinical Trials/NCT06414733
HER-2 B Cell Peptide Vaccine
Is NCT06414733 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51 for metastatic breast cancer.
Treatment: Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51 — 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
Treatments studied
Other
Cancer type
Breast Carcinoma
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression (IHC 1+, 2+, or 3+)
HER-2 (IHC 1+, 2+ and 3+)...to be enrolled on this study
Required: EGFR overexpression
EGFR over-expression (FISH and IHC) to be enrolled on this study
Excluded: HER2 (ERBB2) wild-type
tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification
Excluded: EGFR wild-type
under-expressing EGFR based on FISH and IHC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — metastatic/advanced disease
Patients must have received or refused first line standard systemic therapy for their metastatic/advanced disease.
Cannot have received: cytotoxic chemotherapy
Exception: esophageal cancer: no more than two prior regimens in last two years; breast cancer: no more than three prior regimens in last two years
esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years; breast cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years
Cannot have received: CDK4/6 inhibitor in combination with endocrine therapy
Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6...inhibitors in combination with endocrine therapy
Cannot have received: mTOR inhibitor in combination with endocrine therapy
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 < 3x ULN
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 < 3x ULN. Creatinine <1.5 mg/dl or calculated creatinine clearance > 60 ml/min. Baseline Echocardiogram or MUGA and LVEF within normal limits (or 50% or higher).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06414733 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic chemotherapy, CDK4/6 inhibitor in combination with endocrine therapy, mTOR inhibitor in combination with endocrine therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR overexpression is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 wild-type is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR wild-type is an exclusion criterion.
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 qualify