EO4010 in Previously Treated Metastatic Colorectal Carcinoma

Inclusion Criteria

• 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 Criteria

• 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
• Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments
• Patients under treatment with immunostimulatory or immunosuppressive medications
• Patients who have received treatment with any other investigational agent, or participation in another clinical trial