EO4010 for Colorectal Cancer

(AUDREY Trial)

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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

Open-label multicenter study

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.

Research Team

Jan Fagerberg

Principal Investigator

Enterome

Eligibility Criteria

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.

I am fully active or can carry out light work.

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.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+