Study on EO4010 for Previously Treated Metastatic Colorectal Cancer

Sponsor: Enterome

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05589597

Provider View

This clinical trial is testing a new vaccine, EO4010, combined with the drug nivolumab, to see if it is safe and effective for patients with metastatic colorectal cancer that cannot be removed by surgery and has been previously treated.

Patient Parameters

Program Overview

This study is exploring the safety and potential benefits of a new vaccine called EO4010, used together with the drug nivolumab, for patients with metastatic colorectal cancer that has already been treated and cannot be surgically removed. The trial aims to find out if this combination can help control the cancer and improve patient outcomes.

Description

This clinical trial is an open-label, multicenter study, meaning that both the researchers and participants know what treatment is being given. It is a phase 1/2 trial, which means it is in the early stages of testing. The study is designed to assess the safety, tolerability, immune response, and preliminary effectiveness of the EO4010 vaccine when used with nivolumab. The trial is for patients with metastatic colorectal cancer that has been previously treated and cannot be removed by surgery. Participants will receive the vaccine and drug combination and will be monitored for any side effects and how well the treatment works against their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have a confirmed diagnosis of advanced colorectal cancer that cannot be surgically removed.
  • Have metastatic colorectal cancer that has been treated before or are not suitable for standard treatments.
  • Cancer must have progressed during or within 3 months after the last standard treatment.
  • Be 18 years or older.
  • Have a specific genetic marker called HLA-A2.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer according to standard criteria.
  • Have a life expectancy of at least 3 months.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must follow recommendations for contraception.
  • Be willing and able to comply with study procedures.

Exclusion Criteria

  • Have taken dexamethasone over 2 mg/day within 14 days before starting the study, unless for treating side effects.
  • Have had radiotherapy within 12 weeks or chemotherapy within 28 days before the study.
  • Have ongoing side effects from previous treatments that are moderate or worse.
  • Have received prior treatments targeting PD1, PDL1, CTLA-4, or similar.
  • Have previously taken certain cancer drugs like trifluridine/tipiracil or regorafenib.
  • Have been exposed to similar vaccines as EO4010.
  • Have certain abnormal blood test results, such as low blood cell counts or high liver enzymes.
  • Have had another cancer within the last 3 years, except for certain low-risk cancers.
  • Have significant infections, heart disease, or other serious medical or psychiatric conditions.
  • Have autoimmune disorders or a history of autoimmune neurological conditions.
  • Have had organ or stem cell transplants.
  • Have a history of tuberculosis.
  • Be pregnant or breastfeeding.
  • Have HIV or active hepatitis B or C infections.
  • Have uncontrolled cancer spread to the brain.
  • Have received live vaccines within 4 weeks before the study.
  • Have allergies to study treatments.
  • Be on medications that stimulate or suppress the immune system.
  • Have participated in another clinical trial or received other investigational treatments.

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