Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I study to evaluate the safety and dosimetry of 68Ga-labelled OncoFAP derivatives in patients with solid tumors

This is an early-stage research study, called a Phase I trial, looking into a new method for detecting certain solid cancers. It involves adults with specific types of cancer, including breast, bowel, oesophageal, and pancreatic cancer. The study is investigating a new substance, an 'OncoFAP derivative' labelled with a small amount of radioactive material called 68Ga. Researchers want to understand if this substance is safe when given to people for the first time and how it moves through the body to help create clear images. The main goal is to find the right amount of this substance for future scans. This type of research is crucial for developing better ways to find and treat cancers in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Philogen S.p.A.

Enrolment target

Start

09 Nov 2022

Patients with breast cancer colorectal cancer oesophageal cancer and pancreatic adenocarcinoma.

What is this study about?

Imagine doctors are trying to find a specific type of marker or 'signpost' on some cancer cells. This study is testing a new way to light up these signposts so they can be seen better on a scan. The new substance being tested is like a tiny tracer that goes into your body and attaches itself to these specific cancer markers. When it attaches, a special scanner can then see it, hopefully showing exactly where the cancer cells are.

The main aim of this first-stage study is to check if this new substance is safe for people. Since it's the very first time it's being used in humans, doctors need to be very careful. They also want to work out the best amount of the substance to give to get clear pictures without using too much. This is called 'dosimetry' – finding the right dose.

By testing this in patients with certain cancers like breast, bowel, food pipe (oesophageal), and pancreatic cancer, researchers hope to see if it works as expected. If it proves to be safe and the right dose can be found, it could lead to much clearer and more accurate scans in the future, helping doctors to better understand and treat these conditions.

Key takeaways

This is an early-stage study testing a new way to scan for certain cancers.
It aims to check the safety and find the best dose of a new substance.
Participation is for adults aged 18 and over with specific solid tumours.
It involves detailed scans and close health monitoring.
This is not a treatment study, but aims to improve future cancer diagnosis.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate. The study is specifically looking for people who have been diagnosed with certain types of solid tumours.

These specific cancers include breast cancer, bowel (colorectal) cancer, cancer of the food pipe (oesophageal cancer), and a type of pancreatic cancer called pancreatic adenocarcinoma. Your medical team will need to confirm your specific cancer diagnosis meets the study's requirements.

There will be other health checks and criteria that your doctor will review to make sure this study is right and safe for you. They will discuss all these details with you if you are interested in taking part.

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 diagnosis of breast cancer, bowel cancer, oesophageal cancer, or pancreatic adenocarcinoma?
Are you available for multiple hospital visits and scans?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be among the first people to receive this new substance. You would have a series of appointments, which would likely include various health assessments like blood tests, physical examinations, and detailed scans before, during, and after receiving the trial substance. The substance would be given to you, probably through a drip into your arm.

After receiving the substance, you would have several scans to see how it moves through your body and where it collects. These scans help doctors understand its safety and how much is needed. There would also be follow-up appointments to monitor your health and any effects of the substance. The exact number of visits and the total duration of your participation would be explained in detail by the study team, but typically, early-stage studies involve close monitoring over a period of weeks to a few months.

Potential risks and benefits

Taking part in a study like this means you might be helping to discover new ways to diagnose cancer, which could benefit many people in the future. However, because this is the first time this substance is being given to humans, there might be unknown risks or side effects that doctors are not yet aware of. You might experience some mild side effects from the substance or the scan procedures, or potentially more serious ones, though these are carefully watched for. Your well-being is paramount, and you would be closely monitored throughout the study. Remember, if you join, you are always free to change your mind and 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 does 'Phase I study' mean?

It means this is the first time the new substance is being tested in humans. The main goal is to check for safety and find the right amount to use.

Why is it called '68Ga-labelled OncoFAP'?

68Ga refers to a small amount of radioactive material that helps the substance show up on a special scan, and OncoFAP is the part designed to attach to cancer cells.

What kind of scans would I have?

You would likely have special scans that can pick up the radioactive material to see where it goes in your body and if it attaches to cancer cells.

Will I get this treatment if I join?

This study is not a treatment. It's about finding a better way to *diagnose* or *see* certain cancers using scans, not to treat the cancer itself.

Will this study help my cancer directly?

While the aim is to improve diagnosis, this study itself is primarily to learn about the safety and effectiveness of the scanning substance. Any direct benefit to your own cancer is not guaranteed.