EO4010 in Previously Treated Metastatic Colorectal Carcinoma
Reason given: Sponsor decision to stop recruitment in context of overall EO4010 development goals. Stop of recruitment was not related to any safety concern, with the safety profile of EO4010 being benign
Key facts
- Where
- Besançon, Montpellier, and Paris, FranceSee the 3 sites
- Phase
- Phase 1/2
Where in France
- Hopital Jean MinjozBesançon, FranceNo longer taking part
- ICM Val d'AurelleMontpellier, FranceNo longer taking part
- Saint-Antoine HospitalParis, FranceNo longer taking part
Trial details
- Who runs it
- Enterome
- Trial code
- NCT05589597
- Record updated
- 19 October 2026
- Original description
Open-label multicenter studyRead full original descriptionShow less
A Global Multicenter Phase 1/2 Trial of EO4010, a Novel Microbial Derived Peptide Therapeutic Vaccine, in Combination With Nivolumab and/or Bevacizumab, for Treatment of Patients With Previously Treated Metastatic Colorectal Carcinoma
Open-label multicenter study
Inclusion: 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.
Exclusion: 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 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 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; Patients under treatment with immunostimulatory or immunosuppressive medications; Patients who have received treatment with any other investigational agent, or participation in another clinical trial; 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; Patients with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition; Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome); Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation; Patients with a history or known presence of tuberculosis; Patients with a history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV); Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments; 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); Abnormal thyroid function per local laboratory levels; 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; Pregnant and breastfeeding patients; Uncontrolled central nervous system (CNS) metastasis.