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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.

NCT06746688 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Gouya Insights

    collaborator UNKNOWN

  • VelaLabs

    collaborator UNKNOWN

  • KKS MedUni Vienna

    collaborator UNKNOWN

  • ExpreS2ion Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Thomas K. Jorgensen · ExpreS2ion Biotechnologies

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746688 on ClinicalTrials.gov