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Colorectal Cancer MetastaticPhase 1/2AUDREYNCT05589597

EO4010 in Previously Treated Metastatic Colorectal Carcinoma

A Phase 1/2 study testing EO4010 in people with Colorectal Cancer Metastatic, run by Enterome at 6 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Open-label multicenter study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
EO4010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesin 3 countries
Study dates
1 Jun 2023to 30 May 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provided written informed consent
  • Histological confirmation of advanced non-resectable colorectal adenocarcinoma
  • Patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for
  • Progression during or within 3 months following the latest administration of standard therapies
  • Age ≥ 18 years old
  • Human leukocyte antigen (HLA)-A2 positive
Show all 12Show fewer
  • ECOG performance status 0 or 1
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria (RECIST)
  • Patients with a life expectancy of at least 3 months
  • Female patients of childbearing potential must have a negative serum pregnancy test
  • Patients following recommendations for contraception
  • Patients willing and able to comply with the study procedures

Who cannot join

  • Patients treated with dexamethasone > 2 mg/day or equivalent within 14 days before randomization, unless required to treat an adverse event
  • Patients treated with radiotherapy within 12 weeks, and cytotoxic chemotherapy therapy within 28 days
  • Patients with persistent Grade ≥ 2 toxicities (according to NCI-CTCAE v5.0). Toxicities must be resolved for at least 2 weeks to Grade 1 or less
  • Patients who have received any prior treatment with compounds targeting PD1, PDL1, CTLA-4, or similar compounds
  • Patients who have previously received trifluridine/tipiracil (TAS-102) or regorafenib
  • Patients with prior exposure to EO2401, EO2040, or EO4010, i.e. therapeutic vaccine compounds including all or some components of EO4010
Show all 28Show fewer
  • Patients with the following abnormal laboratory values:
  • Lymphocyte count decreased, grade 2 (lymphocytes <800 - 500/mm3; <0.8 - 0.5 x 109/L), or worse grade
  • Hemoglobin < 10 g/dL (6.2 mmol/L); transfusion is acceptable to reach the value
  • Absolute neutrophil count decrease (<1.5 x109/L)
  • Platelet count decrease (< 75 ×109/L)
  • Total bilirubin > 1.5 ×upper limit of normal
  • Alanine aminotransferase (ALT) > 3 ×ULN; if disease metastatic to the liver > 5 xULN
  • Aspartate aminotransferase (AST) > 3 ×ULN; if disease metastatic to the liver > 5 xULN
  • Serum creatinine increase (> 1.5 ×ULN)
  • Abnormal thyroid function per local laboratory levels
  • Other malignancy or prior malignancy with a disease-free interval of less than 3 years prior to ICF signing; except those treated with surgical intervention and an expected low likelihood of recurrence
  • Patients with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition
  • Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome)
  • Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Patients with a history or known presence of tuberculosis
  • Pregnant and breastfeeding patients
  • Patients with a history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV)
  • Uncontrolled central nervous system (CNS) metastasis
  • Patients who have received live or attenuated vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug
  • Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments
  • Patients under treatment with immunostimulatory or immunosuppressive medications
  • Patients who have received treatment with any other investigational agent, or participation in another clinical trial

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

France3 sites

  • Hôpital Jean Minjoz

    Besançon, 25030

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Saint Antoine hospital

    Paris, 75012

Other trials in France

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Llavero-Hospital Clínico Universitario

    Valencia

Other trials in Spain

United States1 site

  • MD Anderson

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Global Multicenter Phase 1/2 Trial of EO4010, a Novel Microbial Derived Peptide Therapeutic Vaccine, in Combination With Nivolumab and/or Bevacizumab, for Treatment of Patients With Previously Treated Metastatic Colorectal Carcinoma

Open-label multicenter study

Read the detailed description

This is an open-label, multicenter, FIH, phase 1/2 trial to assess safety, tolerability, immunogenicity, and preliminary efficacy of the microbial-derived therapeutic vaccine EO4010 in combination with nivolumab and/or bevacizumab for treatment of patients with unresectable, previously treated, metastatic colorectal cancer

Being tested
EO4010

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EO4010Drug

    Also called Nivolumab, Bevacizumab

    Sequential assignment

Study groups in NCT05589597
Study groupRoleWhat they receive
Cohort 1ExperimentalE04010 Monotherapy
Receives: Drug: EO4010
Cohort 2ExperimentalE04010 in combination with nivolumab
Receives: Drug: EO4010
Cohort 3ExperimentalE04010 in combination with nivolumab and/or bevacizumab
Receives: Drug: EO4010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of EO4010 in Combination With Nivolumab and/or Bevacizumab

    Incidences of treatment-emergent Serious Adverse Events (SAEs) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

    Measured: 24 months

Secondary outcomes (7)

  1. Percentage of Patients With Shown Immunogenicity Againts EO4010 (All Peptides)

    Immunogenicity response of EO4010 (all peptides) for the three tests together: IFN-gamma ElISpot [IVS], IFN-gamma ElISpot [NS], multimer staining [NS].

    A patient is defined as positive if the result of one of the three tests (IFN-gamma ElISpot [IVS], IFN-gamma ElISpot [NS], multimer staining [NS]) shows a positive response

    Measured: Week 5 after first dose of EO4010

  2. Overall Response Rate

    Defined as the percentage of patients who have a partial or complete response following Response Evaluation Criteria in Solid Tumors criteria

    Measured: 24 months

  3. Disease Control Rate

    Defined as the percentage of patients who have achieved complete response, partial response or stable disease following Response Evaluation Criteria in Solid Tumors criteria

    Measured: 24 months

  4. Time to Response

    Defined as the time interval from first study treatment administration to partial or complete response following Response Evaluation Criteria in Solid Tumors criteria

    Measured: 24 months

  5. Duration of Response

    Defined as the time interval from first study treatment administration to disease progression or death in patients who achieve complete or partial response following Response Evaluation Criteria in Solid Tumors criteria

    Measured: 24 months

  6. Progression Free Survival

    Defined as the time interval from the date of first study treatment administration to the date of progression following Response Evaluation Criteria in Solid Tumors criteria

    Measured: 24 months

  7. Overall Survival to the Date of Death Due to Any Cause. Patients Alive Will be Censored at the Date of the Last Documented Follow-up

    Defined as the time interval from the date of first study treatment administration to the date of death due to any cause. Patients alive will be censored at the date of the last documented follow-up

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start1 Jun 2023
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Why it stopped: Sponsor decision to stop recruitment in context of overall EO4010 development goals. Stop of recruitment was not related to any safety concern, with the safety profile of EO4010 being benign

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Multi-cohort
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05589597
Sponsor's protocol ID
EOCRC2-22
Acronym
AUDREY
Status last verified
Oct 2026
First submitted
14 Oct 2022
Last updated
19 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EO4010 in people with Colorectal Cancer Metastatic, run by Enterome at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of EO4010 in Combination With Nivolumab and/or Bevacizumab (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05589597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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