RecruitingPhase 1NCT06414733

HER-2 B Cell Peptide Vaccine

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors

Sponsor

Pravin T.P Kaumaya

Enrollment

42 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer HER2-positive Breast Cancer Metastatic Gastrointestinal Carcinoma HER2-positive Gastric Cancer EGFR Overexpression

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a HER2-targeted B-cell peptide vaccine in patients with metastatic or unresectable breast cancer or gastrointestinal cancers. HER2 is a protein that promotes cancer cell growth. The vaccine aims to trigger the immune system to recognize and attack HER2-expressing cancer cells. **You may be eligible if...** - You have metastatic or unresectable breast cancer, or - You have metastatic or unresectable gastrointestinal cancer - Your diagnosis has been confirmed by biopsy - You have measurable disease (for certain study cohorts) **You may NOT be eligible if...** - You do not have one of the specified cancer types - Your cancer cannot be confirmed or measured - Your overall health or prior treatment history does not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCombination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720

Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified in ISA 720 vehicle. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with a Montanide ISA 720, and will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots.

Locations(1)

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianpolis, Indiana, United States

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NCT06414733

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