Not yet recruitingPHASE1INTERVENTIONAL

Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer

This is an early-stage research study (Phase 1) testing a new, personalised treatment called ODI-2001 for people with advanced bowel (colorectal) or pancreatic cancer that has spread or is hard to remove. The main goal is to see if this treatment is safe and can be given to patients. Researchers will also be looking to see how well it works to control the cancer. The personalised treatment combines a special DNA vaccine tailored to your cancer, a virus to boost the immune response, and another drug called ipilimumab. The study will start by finding the safest and most effective dose, then offer it to more patients to see its effects on the cancer's growth.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Centre Georges Francois Leclerc

Enrolment target

Start

01 Nov 2026

Estimated completion

01 May 2031

Metastatic Colorectal Cancer (CRC)Locally Advanced Colorectal Cancer Metastatic Pancreatic Cancer Locally Advanced Pancreatic Cancer

What is this study about?

This research study is looking at a new type of treatment for advanced bowel or pancreatic cancer. This treatment is called ODI-2001 and it's a personalised cancer vaccine. This means it's designed to specifically target your cancer. It combines three different parts: a special DNA vaccine created based on your cancer's unique features, a modified virus (called MVA) to help kickstart your immune system, and a drug called ipilimumab, which is already used to help the immune system fight cancer.

The main aim of this early-stage study (Phase 1) is to understand if this new treatment is safe for people with advanced bowel or pancreatic cancer. Researchers also want to find the best dose to give and see if it's practical to deliver this personalised treatment. Finally, they will be checking to see if it helps to slow down or stop the cancer from growing.

This study is important because it explores a new way to use the body's own immune system to fight cancer. By creating a personalised vaccine, the hope is to give a more targeted and effective treatment with potentially fewer side effects than traditional chemotherapy.

Key takeaways

This is an early-stage study (Phase 1) of a new personalised vaccine for advanced bowel or pancreatic cancer.
The treatment involves a special vaccine, a virus to boost immunity, and an existing cancer drug.
The study aims to see if the treatment is safe, feasible, and to find the best dose.
It also looks at how well the treatment helps control the cancer's growth.
Participants would receive the study treatment in addition to their standard chemotherapy.
Your health and cancer progress would be closely monitored throughout the study.

Who may be eligible?

To join this study, you would generally need to be an adult over 18 years old and have a confirmed diagnosis of advanced bowel (colorectal) or pancreatic cancer that cannot be removed by surgery or treated with other local methods. Your cancer should also be a specific type of bowel cancer (microsatellite stable).

Additionally, you should be well enough to carry out most daily activities, with a good overall health status (doctors use something called an 'ECOG score' of 0 or 1 for this). You would also need to be suitable to start standard first-line chemotherapy for your cancer type.

There are also specific blood test results for your liver, kidneys, and blood cells that need to be within a healthy range to ensure you can safely receive the treatment. Your heart function will also be checked with an ECG.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I over 18 years old?
Do I have advanced bowel (colorectal) or pancreatic cancer?
Is my cancer not suitable for surgery or other local treatments?
Do I feel generally well and able to carry out most daily activities?
Am I suitable to start my first course of chemotherapy?
Do I have normal enough blood test results for my liver, kidneys, and blood cells?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a thorough check-up, including blood tests and scans, to make sure you're suitable for the study. The study involves receiving the personalised vaccine treatment alongside your standard first-line chemotherapy for bowel or pancreatic cancer. The exact number of visits and tests would be explained in detail by the study team.

Initially, the study will involve finding the best dose of the personalised vaccine. This might mean you are in a group that receives a lower dose at first, which might gradually increase. You would have regular assessments, including blood tests and scans (like CT scans of your chest, tummy, and pelvis), to monitor your health, check for any side effects, and see how the treatment is affecting your cancer. These scans will look for changes in the size of your cancer.

The total duration of your participation would vary, but you would be regularly monitored throughout the treatment period and for a follow-up period afterwards. The research team will explain the full schedule of appointments and treatments.

Potential risks and benefits

Taking part in a research study always has potential benefits and risks. A potential benefit of joining this study is that you might receive a new, personalised treatment that could help control your cancer, which is not yet available outside of clinical trials. However, there's no guarantee the treatment will work for you, and it might not be more effective than standard treatments. Potential risks include side effects from the new vaccine treatment, which are not fully known yet, and additional tests or procedures. The study team will explain all known and potential side effects. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (2)

CHRU Jean Minjoz
Verified postcode
Besançon, France
Centre Georges-François Leclerc
Verified postcode
Dijon, France

Common questions

What is a 'personalised' cancer vaccine?

It's a vaccine specifically designed to target unique features of your cancer, aiming to help your own immune system recognise and fight it.

What is a Phase 1 study?

It's the first stage of testing a new treatment in humans. The main goals are to check if it's safe, find the right dose, and see if it's possible to give.

What types of cancer is this study for?

This study is for people with advanced bowel (colorectal) cancer or pancreatic cancer that has spread or can't be removed by surgery.

Will I still receive standard chemotherapy?

Yes, you would receive the new personalised vaccine treatment alongside your usual first-line chemotherapy for your cancer type.

What is 'efficacy' in this study?

Efficacy means how well the treatment works. In this study, they're looking at things like how long the cancer stays stable without growing (called 'progression-free survival').

How to find out more

François FG GHIRINGHELLI, Pr

fghiringhelli@cgfl.fr 03 45 34 75 38 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.