Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06414733

HER-2 B Cell Peptide Vaccine

Led by Pravin T.P Kaumaya · Updated on 2025-08-24

42

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HER-2 B Cell Peptide Vaccine

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed metastatic or unresectable breast or gastrointestinal cancer
  • Patients must have measurable disease (at least one lesion ≥20 mm by conventional methods or ≥10 mm by spiral CT)
  • Received or refused first line standard systemic therapy; no more than two prior chemotherapy regimens for pancreatic and esophageal cancers in last 2 years
  • No more than three prior chemotherapy regimens in last 2 years for breast and gastrointestinal cancers
  • Disease progression after at least one line of standard therapy
  • HER-2 expression (IHC 1+, 2+, or 3+) or EGFR overexpression confirmed by IHC or FISH
  • Prior treated brain metastases allowed if stable and off steroids for at least 3 months
  • ECOG performance status 0, 1, or 2
  • Adequate organ function including ANC ≥1000/mm³, platelet count >700,000/mm³, bilirubin <1.5 mg%, ALT <2 times upper limit, creatinine <1.5 mg/dl or clearance >60 ml/min
  • At least 3 weeks since prior surgery, chemotherapy, immunotherapy, hormonal therapy, or radiation
  • Stable endocrine therapy allowed if hormone receptor positive breast cancer with HER-2 IHC 1+ or 2+
  • Age 18 years or older
  • Women of childbearing potential must have negative pregnancy test and both men and women must agree to use contraception
  • Baseline echocardiogram or MUGA with left ventricular ejection fraction ≥50%
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Tumors negative for HER-2 expression by IHC 0 and FISH lacking HER-2 amplification or under-expressing EGFR
  • Use of certain targeted therapies like CDK 4/6 or mTOR inhibitors combined with endocrine therapy
  • Positive immediate hypersensitivity skin test to the vaccine peptides
  • Active infection requiring antibiotics or not clear of infection for at least 3 weeks
  • Known active HIV, hepatitis A, B, or C infection
  • Serious uncontrolled heart or lung disease or other uncontrolled medical illnesses
  • Current or likely need for corticosteroids or immunosuppressive drugs
  • History of splenectomy
  • Active autoimmune diseases such as rheumatoid arthritis, lupus, scleroderma, polymyositis, or vasculitis
  • Previous anaphylactic reaction to other vaccines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianpolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

X

Xin Bryan, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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