AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Patients with Injectable Solid Tumors.

This research study is looking at a new potential treatment called TILT-123 for people who have certain types of solid cancers that doctors can inject directly into. The main goals of this early-stage study (Phase 1) are to find out if TILT-123 is safe, what dose works best, and how the body reacts to it. Researchers will be carefully checking for any side effects. This treatment involves using a modified virus designed to target cancer cells and help the body's immune system fight the cancer. Because it's an early study, there's still a lot to learn about TILT-123. If you're considering taking part, your doctor will explain everything in detail.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

TILT Biotherapeutics Oy

Enrolment target

Start

20 Dec 2024

Solid Tumors

What is this study about?

This study is investigating a new and experimental treatment for people who have solid tumors. Solid tumors are types of cancer that form a lump, such as breast, lung, or bowel cancer, rather than blood cancers like leukemia. The treatment being tested is called TILT-123. It's a special kind of 'oncolytic virus,' which means it's a modified virus designed to infect and destroy cancer cells while leaving healthy cells alone. Think of it like a smart virus that's been reprogrammed to attack only cancer.

What makes TILT-123 special is that it's designed to carry instructions for your body to produce two natural chemicals: Tumor Necrosis Factor Alpha and Interleukin-2. These chemicals are important parts of your immune system, and they help boost the body's natural ability to fight off diseases, including cancer. By delivering these instructions directly into the tumor, the hope is to make the cancer cells more vulnerable and encourage your own immune system to recognise and attack them more effectively.

This is a 'Phase 1' study, which is the very first step in testing a new treatment in humans. At this stage, the main focus is on safety. Doctors want to find out if TILT-123 is safe for people, what the best dose is, and whether there are any serious side effects. They will also be looking for early signs of how the treatment affects the cancer. Finding out if it works well enough to treat cancer is usually a goal of later-stage studies, but any positive signs are important. The study is 'open-label,' meaning both you and your doctors will know you are receiving TILT-123.

Key takeaways

This is an early-stage study (Phase 1) testing a new cancer treatment called TILT-123.
TILT-123 uses a modified virus to target solid tumors and boost the immune system.
The main goals are to check for safety, find the best dose, and understand how the treatment works.
The treatment involves injections directly into an injectable solid tumor.
Participation is voluntary, and you can withdraw at any time.
Your medical team will decide if this study is suitable for you based on strict criteria.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 years or older. This study is open to both men and women.

There will be specific medical conditions or previous treatments that might mean you can't join the study. For example, your doctors will check what type of solid tumor you have and whether it can be injected directly. They will also look at your general health, organ function (like your liver and kidneys), and other medications you might be taking to ensure it's safe for you to participate.

Because this is an early-stage study, the rules for who can join are usually quite strict to ensure patient safety. Your oncology team will carefully review all your medical information against a detailed list of criteria to determine if this study is suitable for you.

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.

Are you 18 years old or older?
Do you have a solid tumor that doctors can inject directly?
Are you able to attend regular hospital visits and follow-up appointments?
Are you generally in good enough health, as determined by your doctor, to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo a number of tests. These will help the doctors confirm that you meet all the requirements for the study and establish a baseline picture of your health. These tests might include blood tests, scans (like CT or MRI), and physical examinations.

Your treatment will involve receiving TILT-123 directly into your injectable solid tumor. The doctors will start with a very low dose in the first group of patients and, if it's safe, gradually increase the dose for later groups. This is how they figure out the best and safest dose. You will likely have regular hospital visits for treatments and close monitoring. These visits will involve blood tests, physical exams, and possibly further scans to see how you are responding and to check for any side effects.

After your treatment period, there will be follow-up appointments. These are important for doctors to continue monitoring your health and any long-term effects of the treatment. The total duration of your participation, including follow-up, will be clearly explained by the study team before you make any decisions.

Potential risks and benefits

Participating in an early-stage study like this means you are receiving a new treatment, the full benefits and risks of which are not completely known. A potential benefit is that TILT-123 might help fight your cancer when other treatments haven't been as effective. However, there's also a chance it may not help your cancer at all. Potential risks could include side effects from the treatment, some of which might be mild (like fever or fatigue) and others potentially more serious. Your doctors will carefully explain all known and potential risks. It's important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Finland

Common questions

What is a 'solid tumor'?

A solid tumor is a lump of abnormal cells that forms in a part of the body, like breast cancer or lung cancer. It's different from blood cancers like leukemia.

What does 'oncolytic adenovirus' mean?

It means the treatment uses a modified virus (a type of common cold virus) that has been changed in the lab to infect and destroy cancer cells specifically, while trying to leave healthy cells alone.

What is a 'Phase 1' study?

A Phase 1 study is the very first stage where a new treatment is tested in humans. The main goal is to check its safety, find the right dose, and understand how the body reacts to it, rather than primarily checking how well it works.

Will I know if I'm getting the actual treatment?

Yes, in this 'open-label' study, both you and your doctors will know that you are receiving the TILT-123 treatment. There is no placebo.

Can I stop participating in the study if I want to?

Yes, absolutely. Taking part is entirely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual hospital care.