Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A phase I study of [177Lu]Lu-FF58 in patients with advanced solid tumors

This research study is about a new medicine called [177Lu]Lu-FF58. It's being tested for people who have advanced solid tumours, specifically certain types of brain cancer (glioblastoma), pancreatic cancer, or stomach cancer (gastroesophageal adenocarcinoma) that have either come back or cannot be removed by surgery. This is a very early study, called a Phase I and Phase II trial. This means it's the first time this medicine is being given to people. The main goals are to check if the medicine is safe, to understand any side effects, and to find the right amount (dose) to give. Researchers also want to see if the medicine helps against these cancers. It's open to all adults, regardless of their age or sex.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

28 Jul 2023

Recurrent glioblastoma multiforme (GBM)Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)Locally advanced unresectable or metastatic gastroesophageal adenocarcinoma (GEA)

What is this study about?

This study is looking into a new treatment for certain advanced cancers that have become difficult to treat with standard methods. These cancers include a type of brain tumour called glioblastoma multiforme that has returned, as well as pancreatic cancer and stomach/oesophageal cancer that has spread or cannot be removed by surgery. The new treatment is a medicine called [177Lu]Lu-FF58.

This is a very early stage of research, often called a "first-in-human" study (Phase I and Phase II). This means doctors are testing this specific medicine in people for the very first time. The main aim is to carefully check if the medicine is safe to use and to see what dose might work best. They will also be looking to understand any side effects it might have.

Even though it's an early study, researchers will also be watching to see if the medicine has any positive effects on the cancer. Taking part in this kind of study helps scientists learn more about new ways to fight cancer, which could potentially help many people in the future.

Key takeaways

It's a new, early-stage study for advanced cancers.
The medicine, [177Lu]Lu-FF58, is being tested in people for the first time.
It's for specific types of advanced brain, pancreatic, or stomach/oesophageal cancer.
The main goals are to check safety, find the right dose, and look for benefits.
Participants will receive the new medicine and have regular medical checks.

Who may be eligible?

This study is open to adults who are at least 18 years old – there is no upper age limit. Both men and women can join.

You would be considered for this study if you have one of the specific advanced cancers mentioned: recurring glioblastoma (a type of brain cancer that has come back), or pancreatic or gastroesophageal (stomach/oesophageal) cancer that is advanced and cannot be removed by surgery or has spread to other parts of the body.

There will be other detailed health checks to make sure the study medicine is right for you and won't put your health at unnecessary risk. Your doctor will carefully review all your medical information to see if you meet all the necessary requirements.

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 advanced glioblastoma (returned), or advanced pancreatic cancer, or advanced stomach/oesophageal cancer?
Has your doctor told you that your cancer cannot be removed by surgery or has spread?
Are you willing to have regular hospital visits and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new study medicine, [177Lu]Lu-FF58. The study involves regular visits to the hospital or clinic. These visits will include various tests such as blood tests, scans (like CT or MRI), and physical examinations to closely monitor your health and how your body is reacting to the treatment. You will also be asked questions about how you are feeling. Doctors will keep a close eye on any side effects.

The number of visits and the duration of your participation will depend on how you respond to the treatment and the phase of the study, but typically these early-stage trials involve frequent monitoring. You'll have a clear schedule of appointments and what to expect during each one. The overall duration is not specified but generally involves treatment cycles followed by a period of observation.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new treatment that isn't widely available yet, which could potentially help your condition. However, because this is an early-stage study, there's always a possibility that the treatment might not work or could have side effects that are not yet fully known. Any new medicine carries potential risks, and the research team will explain all known or expected side effects. Your safety is the most important thing, and you should know that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Netherlands
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Unverified
Italy
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Unverified
Spain

Common questions

What is a Phase I/II study?

It's a very early-stage study where doctors test a new medicine in people for the first time. They focus on finding a safe dose and understanding side effects.

What kind of cancers is this study for?

It's for certain advanced cancers: glioblastoma (a brain cancer that has returned), and pancreatic or stomach/oesophageal cancer that is advanced or has spread.

Will I get the new medicine?

Yes, if you join this study, you will receive the new medicine called [177Lu]Lu-FF58. This is not a study where you might get a placebo (dummy drug).

How long will I be in the study?

The exact duration isn't specified, but it will involve multiple visits for treatment and monitoring. Your doctor can give you a more precise timeline.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time for any reason, and it will not affect your future medical care.