EO4010 for Colorectal Cancer

(AUDREY Trial)

No longer recruiting at 5 trial locations

Overseen By Jan Fagerberg

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Enterome

Must not be taking: Dexamethasone, Immunosuppressants, Immunostimulants, others

Disqualifiers: Autoimmune disorders, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for advanced colorectal cancer that cannot be surgically removed. Researchers are exploring EO4010, a potential new drug, both as a standalone treatment and in combination with drugs like nivolumab and bevacizumab, which assist the immune system in fighting cancer. The trial seeks participants with metastatic colorectal cancer (cancer that has spread) who have tried other treatments and experienced cancer progression within the last three months. Participants must have a specific protein type, HLA-A2, and be able to engage in daily activities without major assistance. As a Phase 1 trial, this research focuses on understanding how EO4010 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the EO4010 trial?

The trial does not specify if you need to stop your current medications, but it excludes those on certain treatments like high-dose dexamethasone or immunosuppressive drugs. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that EO4010, when used alone, is generally safe. It has been tested with nivolumab, a treatment that helps the immune system fight cancer. Earlier studies found that EO4010 is well-tolerated, with serious side effects being uncommon.

When combined with nivolumab, EO4010 remains safe and supports the immune system. Many patients have tolerated it well. Some studies also added bevacizumab, another cancer treatment, to this combination. Early results indicate this mix is also safe. Most patients did not experience serious side effects, and many had stable disease, meaning their cancer did not worsen.

Overall, EO4010, whether used alone or with other treatments, has demonstrated good safety in studies. Serious side effects are rare, and most patients tolerate the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about EO4010 for colorectal cancer because it brings a fresh approach to treatment. Unlike traditional chemotherapy and targeted therapies, EO4010 is explored as a monotherapy and in combination with drugs like nivolumab and bevacizumab. This combination targets the cancer cells differently by potentially enhancing the immune system's ability to fight cancer, offering a new mechanism of action. Additionally, these combinations could lead to more effective treatment regimens with the potential for improved patient outcomes, setting them apart from the current standard of care.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research shows that EO4010 has promising results for treating colorectal cancer. In this trial, participants in Cohort 1 will receive EO4010 monotherapy, which earlier studies found triggered specific immune responses against tumors and led to noticeable tumor shrinkage, even in the liver. Participants in Cohort 2 will receive EO4010 combined with nivolumab, a type of immunotherapy; previous studies reported that about 40% of patients were still alive a year after treatment. Cohort 3 will involve EO4010 combined with both nivolumab and bevacizumab, and some patients experienced stable disease, meaning their cancer did not worsen. These findings suggest that EO4010, whether used alone or with other treatments, might effectively manage colorectal cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Jan Fagerberg

Principal Investigator

Enterome

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced, non-resectable colorectal adenocarcinoma that's HLA-A2 positive. They must have had prior treatment or be unsuitable for standard therapies, have a life expectancy of at least 3 months, and agree to contraception. Exclusions include recent high-dose steroids or chemotherapy, unresolved toxicities, certain abnormal lab values (like low blood counts), active infections including TB/HIV/HBV/HCV, pregnancy/breastfeeding, history of severe allergies to study drug components or autoimmune disorders.

Inclusion Criteria

My colorectal cancer has progressed despite standard treatments or I am not eligible for them.

My colorectal cancer cannot be removed by surgery.

Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria (RECIST)

Exclusion Criteria

I haven't taken more than 2 mg/day of dexamethasone in the last 14 days, unless it was to treat a side effect.

My cancer has spread to my brain and is not under control.

Patients who have received treatment with any other investigational agent, or participation in another clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EO4010 monotherapy or in combination with nivolumab and/or bevacizumab

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

• EO2401
• EO4010

Trial Overview

EO4010 is being tested in this open-label multicenter study on patients with metastatic colorectal cancer who've already undergone treatment. The focus is on the safety and effectiveness of EO4010 as a potential new therapy option.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

E04010 in combination with nivolumab and/or bevacizumab

Group II: Cohort 2 Experimental Treatment 1 Intervention

E04010 in combination with nivolumab

Group III: Cohort 1 Experimental Treatment 1 Intervention

E04010 Monotherapy

Who Is Running the Clinical Trial?

Enterome

Lead Sponsor

Trials

9

Recruited

550+

Citations

1.

enterome.com

enterome.com/news-events/enterome-presents-encouraging-initial-clinical-data-on-eo4010-in-colorectal-cancer-at-esmo-io-2024/

Data from the ongoing Phase 2 of EO4010 ...

Data from the ongoing Phase 2 of EO4010 demonstrate tumor target specific immune responses and objective tumor responses, including in liver ...

2.

enterome.com

enterome.com/news-events/enterome-presents-positive-phase-1-2-mss-pmmr-metastatic-colorectal-cancer-data-in-patients-treated-with-eo4010-oncomimics-immunotherapy-plus-nivolumab-at-asco-2025/

positive Phase 1/2 data from the AUDREY trial

Survival in patients treated with EO4010 plus nivolumab at a median follow-up of 15.4 months, was 40% at 12-months and there is currently a ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05589597

NCT05589597 | EO4010 in Previously Treated Metastatic ...

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention ...

4.

globenewswire.com

globenewswire.com/news-release/2025/05/30/3090836/0/en/Enterome-presents-positive-Phase-1-2-MSS-pMMR-metastatic-colorectal-cancer-data-in-patients-treated-with-EO4010-OncoMimics-immunotherapy-plus-nivolumab-at-ASCO-2025.html

Enterome presents positive Phase 1/2 MSS/pMMR metastatic

Survival in patients treated with EO4010 plus nivolumab at a median follow-up of 15.4 months, was 40% at 12-months and there is currently a ...

5.

lundbeckfonden.com

lundbeckfonden.com/business-activities/biocapital-portfolio-news/enterome-announces-first-patient-dosed-in-a-phase-1/2

Enterome announces first patient dosed in a Phase 1/2 trial ...

EO4010 uniquely mimics five distinct tumor-associated antigens designed to provide multi-targeted, broad tumor coverage, maximizing tumor ...

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3536

Survival of patients (pts) with microsatellite stable/mismatch ...

Conclusions: EO4010 + nivolumab promotes expansion of TAA specific CD8 T cells and shows good safety and interesting survival in previously ...

7.

biospace.com

biospace.com/press-releases/enterome-presents-encouraging-initial-clinical-data-on-eo4010-in-colorectal-cancer-at-esmo-io-2024

Enterome Presents Encouraging Initial Clinical Data on ...

Data from the ongoing Phase 2 of EO4010 demonstrate tumor target specific immune responses and objective tumor responses, including in liver ...

8.

trial.medpath.com

trial.medpath.com/news/db241c08ef9d6f69/enterome-s-eo4010-shows-promising-survival-data-in-difficult-to-treat-colorectal-cancer-at-asco-2025

Enterome's EO4010 Shows Promising Survival Data in Difficult-to ...

Enterome's OncoMimics™ immunotherapy EO4010 combined with nivolumab achieved 40% survival at 12 months in 20 patients with MSS/pMMR metastatic colorectal cancer ...