HER-2 B Cell Peptide Vaccine for Metastatic Cancers

This study is testing a vaccine called MVF-HER-2, which combines two peptides (small protein pieces) with a substance called ISA 720. The goal is to see if this vaccine is safe and what dose works best for people with metastatic (spread to other parts of the body) breast cancer or gastrointestinal (stomach and bowel) cancer that is HER2-positive or has EGFR overexpression. The vaccine aims to help your body's immune system fight cancer cells. Researchers will look at side effects, how your immune system responds, and if the tumor shrinks. You may be eligible if you have metastatic breast or gastrointestinal cancer and are at least 18 years old.

Study design
This is a Phase 1 interventional study planning to enroll 42 participants. It is designed to evaluate the safety and best dose of the vaccine.
What's involved
Participants will receive three intramuscular (into the muscle) injections of the vaccine, each 21 days apart. Safety will be checked regularly for up to one year after the first vaccine.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be checked up to 92 days after your last vaccine injection. Tumor response will be measured up to 71 days after the last vaccine injection, and safety will be monitored for up to one year after the initial vaccine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06414733

HER-2 B Cell Peptide Vaccine

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pravin T.P Kaumaya
~42 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0
Measured over through study completion (i.e. up to 1 year post initial vaccine)
+2 more outcomes measured
Metastatic Breast Cancer
HER2-positive Breast Cancer
EGFR Overexpression
Metastatic Esophageal Carcinoma
HER-2 Positive Esophageal Cancer
1 sites across 1 states
Indiana1
  • Pravin Kaumaya, PhD · PRINCIPAL_INVESTIGATOR · Indiana University

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  • Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0through study completion (i.e. up to 1 year post initial vaccine)
  • Humoral Immune Responsethrough completion of 3 vaccine series (i.e. up to day 92 post final vaccine injection)

    Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296)

  • Overall Response Ratethrough completion of 3 vaccine series (i.e. up to day 71)