Phase I First-in-Human Trial Testing Safety and Immune Response of ES2B-C001 Vaccine With or Without Adjuvant in Patients with HER2-positive Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new vaccine called ES2B-C001, with or without an adjuvant, in patients with HER2-expressing metastatic breast cancer. This first-in-human, open-label, phase I trial aims to find the maximum tolerated dose and study the immune response and early anti-cancer activity of the treatment in patients who have received prior anticancer therapies. Participants will receive ES2B-C001 vaccine every three weeks for a total of five vaccinations. The vaccine may be given alone or combined with an adjuvant called ISA 51 VD. Different dose levels will be tested in separate patient groups, including 50 g, 150 g, and 450 g doses, with or without the adjuvant, to assess safety and immune effects. Throughout the study, lasting up to 18 weeks, patients will be monitored closely through medical evaluations, laboratory tests, and heart assessments to track safety and immune response. Researchers will observe any side effects, measure immune system activation, and look for early signs of anti-tumor activity. Participants health and function will be assessed regularly, with particular attention to heart health and any adverse reactions related to the vaccine or adjuvant.

A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2-expressing Metastatic Breast Cancer.