EO4010 in Previously Treated Metastatic Colorectal Carcinoma
Stopped early · Phase 1/Phase 2
Conditions studied: Colorectal Cancer Metastatic
In brief
Open-label multicenter study
Key facts
- Study ID
- NCT05589597
- Run by
- Enterome
- People needed
- 25
- Starts
- 2023-06-01
- Expected to finish
- 2025-05-30
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
- Abnormal thyroid function per local laboratory levels
- 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
- Pregnant and breastfeeding patients
- Patients with a history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV)
- Uncontrolled central nervous system (CNS) metastasis
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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