EO4010 for Colorectal Cancer
(AUDREY Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Enterome

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Open-label multicenter study

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.

+8 more

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.

+16 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

E04010 in combination with nivolumab and/or bevacizumab

Group II: Cohort 2Experimental Treatment1 Intervention

E04010 in combination with nivolumab

Group III: Cohort 1Experimental Treatment1 Intervention

E04010 Monotherapy