NCT06746688

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.

A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity/Preliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2-expressing Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ExpreS2ion Biotechnologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without \[adjuvant\], in patients with human epidermal growth factor receptor 2 (HER2) expressing metastatic breast cancer.

Conditions

• Breast Cancer
• Breast Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	ES2B-C001	Vaccine; Administration with or without \[adjuvant\] every third week for a total of five vaccinations.
OTHER	ISA 51 VD	Adjuvant; Administration together with ES2B-C001 every third week for a total of five vaccinations.

Timeline

• Start date: 2025-06-03
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-24
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Austria