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

A phase I dose finding study of oral TNO155 in adult patients with advanced solid tumors

This research study is for adult patients diagnosed with advanced solid cancers, which means the cancer has grown or spread. It's an early phase study, meaning it's one of the first times this new medication, TNO155, is being given to people. The main goals are to find out the safest and most effective dose of TNO155. Researchers will also be checking for any side effects and how the body handles the medicine. This is a crucial step in developing new treatments, providing important information before larger studies can take place. It’s open to both men and women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

113

Start

10 Apr 2024

Advanced solid tumors

What is this study about?

This study is an early-stage clinical trial for a new potential cancer treatment called TNO155. When a new medicine is developed, it goes through several careful steps. This particular study is called a 'Phase I' trial. This means it's one of the first times the new drug is being given to people, specifically aiming to understand how it behaves in the human body. The main purpose is not yet to see if it cures cancer, but to find out important information like the safest dose to use and what side effects might occur.

Researchers will be giving TNO155 orally, meaning you would take it by mouth, like a tablet. They want to learn how much of the drug gets into the bloodstream, how long it stays there, and how the body processes it. This information is really important because it helps scientists decide on the right amount of medicine to give in future, larger studies.

The study is specifically for adults with advanced solid tumours. 'Solid tumours' refer to cancers that form a lump, as opposed to blood cancers. 'Advanced' means the cancer has progressed or spread. By carefully studying TNO155 in this group of patients, researchers hope to gather vital data that could lead to new treatment options for solid cancers in the future. It’s a foundational step in bringing new medicines to patients.

Key takeaways

This is an early-stage study (Phase I) for a new cancer medicine, TNO155.
It's for adults with solid cancers that have spread or grown.
The main goals are to find the safest dose and understand side effects.
TNO155 is taken by mouth (orally).
Participation involves regular hospital visits for monitoring and tests.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult patients who have solid cancers that have spread or grown. These are cancers that form a lump, rather than blood cancers, and are considered 'advanced'.

You must be at least 18 years old to be considered for this study, and there is no upper age limit. Both men and women are welcome to take part. Researchers will also check other health factors and previous treatments to make sure the study is a good fit for you and safe for you to join.

It's important to remember that this is an early study, so it's not suitable for everyone. Your doctor will carefully review your full medical history and current health to determine if you meet all the specific requirements to join.

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 18 years old or older?
Do I have an advanced solid tumour?
Am I able to take medication by mouth?
Am I generally well enough to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medication, TNO155, by mouth. This will involve regular visits to the hospital or clinic so the study team can closely monitor your health. During these visits, you can expect to have various assessments, which might include blood tests, physical examinations, and scans to see how your body is reacting to the treatment and to check for any changes in your cancer.

The study aims to find the right dose, so it's possible the dose you receive might change over time, based on how you respond. There will also be a follow-up period after you stop taking the medication, where the doctors will continue to check on your health and any long-term effects. The total length of your participation will vary depending on your individual response and the study's design for your specific group, but your medical team will explain this clearly before you start.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. A potential benefit of joining this study is that you would be among the first to try a new cancer medication, which might help your condition, although this is not guaranteed, especially in an early-stage study. You would also be contributing important information that could help others in the future by advancing medical knowledge. However, there are potential risks, including side effects from the new medication that are currently unknown or not fully understood, as is common with new drugs. Your medical team will explain all known or expected risks. You have the right to withdraw from 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 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually forms a lump, like breast cancer or lung cancer, as opposed to blood cancers like leukaemia.

What does 'advanced' cancer mean in this study?

In this study, 'advanced' means the cancer has progressed, which might include growing larger or spreading to other parts of the body.

Why is this called a 'Phase I' study?

Phase I means it's one of the first times this new drug is being tested in humans. The main goals are to find a safe dose and see how the body handles the medicine.

Will this drug cure my cancer?

At this early stage, the main goal is to find a safe dose and understand the drug. While there's a chance it could help, a cure is not the primary aim of a Phase I study.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect the standard care you receive from your doctors.