Phase 1b Trial of Two HER-2 B Cell Peptide Vaccines with ISA 720 Adjuvant for Advanced Breast and Gastrointestinal Cancers

What this Trial Is About

Researchers are evaluating the safety, side effects, and optimal dose of a vaccine therapy in patients with metastatic solid tumors, including breast and gastrointestinal cancers. This phase I trial studies vaccines made from antibodies and peptides combined with tumor cells to help the body build an immune response to attack tumor cells. The study is led by Pravin T.P Kaumaya and focuses on HER-2 and EGFR-positive cancers. Participants receive a combination vaccine consisting of two HER-2 peptides emulsified in an ISA 720 adjuvant. The vaccine is given as three intramuscular injections spaced 21 days apart, with a possibility of receiving booster shots for up to six months. The trial includes extension and expansion cohorts for patients with metastatic or unresectable breast or gastrointestinal cancers. During the study, participants will be monitored for safety and toxicity using standard criteria up to one year after the initial vaccine. Researchers will measure the immune response, including humoral and T cell function, and overall response rate through the vaccination period. Participants will undergo regular evaluations, including echocardiograms and laboratory tests, to assess organ function and monitor disease progression throughout the study.

HER-2 B Cell Peptide Vaccine