EO4010 in Previously Treated Metastatic Colorectal Carcinoma

NCT ID: NCT05589597

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-05-30

Brief Summary

Open-label multicenter study

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

Conditions

Colorectal Cancer Metastatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

E04010 Monotherapy

Group Type: EXPERIMENTAL

EO4010

Intervention Type: DRUG

Sequential assignment

Cohort 2

E04010 in combination with nivolumab

Group Type: EXPERIMENTAL

EO4010

Intervention Type: DRUG

Sequential assignment

Cohort 3

E04010 in combination with nivolumab and/or bevacizumab

Group Type: EXPERIMENTAL

EO4010

Intervention Type: DRUG

Sequential assignment

Interventions

EO4010

Sequential assignment

Intervention Type: DRUG

Other Intervention Names

Nivolumab; Bevacizumab

Eligibility Criteria

Inclusion Criteria

1. Provided written informed consent

2. Histological confirmation of advanced non-resectable colorectal adenocarcinoma

3. Patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for

4. Progression during or within 3 months following the latest administration of standard therapies

5. Age ≥ 18 years old

6. Human leukocyte antigen (HLA)-A2 positive

7. ECOG performance status 0 or 1

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

9. Patients with a life expectancy of at least 3 months

10. Female patients of childbearing potential must have a negative serum pregnancy test

11. Patients following recommendations for contraception

12. Patients willing and able to comply with the study procedures

Exclusion Criteria

1. Patients treated with dexamethasone > 2 mg/day or equivalent within 14 days before randomization, unless required to treat an adverse event

2. Patients treated with radiotherapy within 12 weeks, and cytotoxic chemotherapy therapy within 28 days

3. 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

4. Patients who have received any prior treatment with compounds targeting PD1, PDL1, CTLA-4, or similar compounds

5. Patients who have previously received trifluridine/tipiracil (TAS-102) or regorafenib

6. Patients with prior exposure to EO2401, EO2040, or EO4010, i.e. therapeutic vaccine compounds including all or some components of EO4010

7. Patients with the following abnormal laboratory values:

1. Lymphocyte count decreased, grade 2 (lymphocytes <800 - 500/mm3; <0.8 - 0.5 x 109/L), or worse grade

2. Hemoglobin < 10 g/dL (6.2 mmol/L); transfusion is acceptable to reach the value

3. Absolute neutrophil count decrease (<1.5 x109/L)

4. Platelet count decrease (< 75 ×109/L)

5. Total bilirubin > 1.5 ×upper limit of normal

6. Alanine aminotransferase (ALT) > 3 ×ULN; if disease metastatic to the liver > 5 xULN

7. Aspartate aminotransferase (AST) > 3 ×ULN; if disease metastatic to the liver > 5 xULN

8. Serum creatinine increase (> 1.5 ×ULN)

9. Abnormal thyroid function per local laboratory levels

8. 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

9. Patients with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition

10. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome)

11. Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation

12. Patients with a history or known presence of tuberculosis

13. Pregnant and breastfeeding patients

14. Patients with a history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV)

15. Uncontrolled central nervous system (CNS) metastasis

16. 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

17. Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments

18. Patients under treatment with immunostimulatory or immunosuppressive medications

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enterome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Fagerberg

Role: STUDY_DIRECTOR

Enterome

Locations

MD Anderson

Houston, Texas, United States

Hôpital Jean Minjoz

Besançon, , France

ICM Val d'Aurelle

Montpellier, , France

Saint Antoine hospital

Paris, , France

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Llavero-Hospital Clínico Universitario

Valencia, , Spain

Countries

United States; France; Spain

Other Identifiers

EOCRC2-22

Identifier Type: -

Identifier Source: org_study_id