AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

First-in-Human Dose Study of IOA-244 in patients with advanced or metastatic cancers.

This study is an early-stage clinical trial for a new medicine called IOA-244. It's designed for people with advanced solid tumours or cancers that have spread (metastatic cancer). This is the very first time this medicine is being given to humans, so the main goals are to check its safety, understand how the body handles it, and find the right dose. It's known as a 'first-in-human' study. Participants will be closely monitored by a medical team. Studies like this are vital for developing new treatments for cancer, though it's important to remember this is a very early step.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

iOnctura SA

Enrolment target

Start

16 Dec 2024

Advanced solid tumours and metastatic cancers

What is this study about?

This study is investigating a new potential cancer treatment called IOA-244. When a new medicine is developed, it goes through several stages of testing to make sure it's safe and effective. This particular study is in the very first stage where humans are involved, often called a 'Phase I' or 'first-in-human' study.

The main purpose of this initial study is to carefully test IOA-244 in people for the first time. The doctors and researchers want to find out if it's safe, how much of it people can take without experiencing severe side effects, and how the body processes the medicine. They also want to see if there are any early signs that it might be helpful in treating certain cancers.

This study is for people who have advanced solid tumours (cancers that form a lump, like lung or breast cancer) or metastatic cancers. Metastatic cancer means the cancer has spread from where it started to other parts of the body. Finding new ways to treat these types of cancers is very important, and studies like this are a crucial step in that process.

Key takeaways

This is an early-stage study for a new cancer medicine.
The main goals are to check safety and find the right dose.
It's for adults with advanced solid tumours or metastatic cancers.
Participants will be closely checked by doctors.
Potential benefits are unknown, and side effects are possible.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, either male or female, and at least 18 years old. There is no upper age limit mentioned.

You must have a type of advanced cancer that is a 'solid tumour' (meaning it grows as a lump, rather than a blood cancer) or cancer that has spread to other parts of your body. This cancer must also be considered 'advanced,' meaning it has progressed or is not responding to standard treatments.

There will also be other important health requirements, and perhaps some types of previous cancer treatments or current medicines that might prevent you from joining. The study team will review your full medical history to see if this study is right 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 an advanced solid tumour or cancer that has spread?
Are you comfortable undertaking regular hospital visits?
Do you understand this is a very early-stage trial of a new medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine, IOA-244. As this is the first time the medicine is being given to humans, you will be very closely monitored by the study team. This will involve regular visits to the clinic for medical check-ups, blood tests, and other assessments to see how you are doing and how your body is reacting to the medicine. The number of visits, tests, and the length of your participation will be explained in detail by the study team. You will be monitored throughout the treatment and for a period afterwards to track any effects of the medicine.

Potential risks and benefits

Taking part in a study like this means you might be among the first to receive a new medicine that could potentially help you. However, because it's new, the benefits are not guaranteed, and there's a chance the medicine might not work for you. There are always potential risks and side effects with any new medicine, which could be unknown at this early stage. The study team will explain all known and possible side effects, and you will be carefully monitored for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is a 'first-in-human' study?

It's the very first time a new medicine is given to people. It's done to check for safety and find the right dose, not primarily to cure a disease yet.

What kind of cancer is this study for?

It's for people with advanced solid tumours or cancers that have spread to other parts of the body (metastatic cancer).

Will I get better if I join this study?

While the medicine might help some people, the main goal of this early study is to check its safety and how it works, not to guarantee a cure. It's too early to know how effective it is.

What does 'advanced' cancer mean in this study?

It typically means your cancer has either grown, spread, or is not responding well to standard treatments anymore.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your current or future medical care.