NCT04116658

First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma

A Multicenter, Open-Label, First-in-Human, Phase 1b/2a Trial of EO2401, a Novel Multipeptide Therapeutic Vaccine, With and Without Check Point Inhibitor, Following Standard Treatment in Patients With Progressive Glioblastoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Enterome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma.

Detailed description

This is a multicenter, Phase 1b/2a, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma. EO2401 is an innovative cancer peptide therapeutic vaccine based on the homologies between Tumor Associated Antigens and microbiome-derived peptides that will be administered alone and in combination with nivolumab, and nivolumab/bevacizumab to generate preliminary safety and efficacy data in patients with progressive glioblastoma.

Conditions

• Glioblastoma, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Multiple dose of EO2401	Multiple dose administration of EO2401 coadministered with or without nivolumab (and bevacizumab, US only) during the priming phase

Timeline

• Start date: 2020-07-13
• Primary completion: 2024-03-04
• Completion: 2024-03-04
• First posted: 2019-10-04
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

10 sites across 4 countries: United States, France, Germany, Spain

Regulatory

• FDA-regulated drug study