EO4010 in Previously Treated Metastatic Colorectal Carcinoma

NCT05589597 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: EOCRC2-22
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 6

Brief Summary

Open-label multicenter study

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of EO4010 in combination with nivolumab and/or bevacizumab

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

  12months

Secondary Outcomes (7)

• Percentage of patients with shown immunogenicity

  12 months

• Overall response rate

  12 months

• Disease control rate

  12 months

• Time to response

  12 months

• Duration of response

  12 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

E04010 Monotherapy

Drug: EO4010

Cohort 2

EXPERIMENTAL

E04010 in combination with nivolumab

Drug: EO4010

Cohort 3

EXPERIMENTAL

E04010 in combination with nivolumab and/or bevacizumab

Drug: EO4010

Interventions

EO4010 DRUG

Sequential assignment

Also known as: Nivolumab, Bevacizumab

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Enterome: lead

Study Sites (6)

MD Anderson

Houston, Texas, 77030, United States

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

Saint Antoine hospital

Paris, 75012, France

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Llavero-Hospital Clínico Universitario

Valencia, Spain

Location

MeSH Terms

Interventions

Nivolumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jan Fagerberg

  Enterome

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-cohort

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 21, 2022
• Study Start: June 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ES (2); FR (3)