RecruitingPHASE1, PHASE2INTERVENTIONAL

A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies

This is a new study called a 'Phase 1/2' trial, which means it's an early step in testing a new medication named CT7439. The main goal is to check how safe CT7439 is and whether people can tolerate it when taken as capsules. It's being tested in people who have solid tumours, which are common types of cancer. Initially, the study will give CT7439 by itself to find the best dose. Later, it might be combined with other cancer treatments. The study aims to understand how the body handles the medicine and if it shows any positive effects. People taking part will continue treatment as long as it's helping and not causing too many side effects, or until they choose to stop.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Carrick Therapeutics Limited

Enrolment target

Start

16 Aug 2024

Estimated completion

22 May 2026

Solid Malignancies

What is this study about?

This study is a clinical trial designed to test a new medication called CT7439. It's for people who have solid tumours, which are cancers that form a lump rather than being in the blood, like leukaemia. The main aim of this early-stage study is to make sure CT7439 is safe to use and to find the best dose that people can comfortably take. This is a very important step because, before any new medicine can be widely used, doctors need to understand its potential effects and how the body reacts to it.

Initially, participants in the study will take CT7439 capsules on their own (as a 'monotherapy'). The doctors will start with very small doses and gradually increase them for different groups of people. This careful approach helps them figure out the lowest dose that might be helpful and the highest dose that can be given safely without too many side effects. A team of experts, including doctors involved in the study, will closely watch everyone's safety and how the medicine is working. They'll use this information to decide on the best dose for future parts of the study.

As the study progresses, if CT7439 is found to be safe and well-tolerated on its own, the researchers might then explore giving it in combination with other existing cancer treatments. This two-part approach (first by itself, then potentially with other treatments) helps researchers build a complete picture of how CT7439 could be used in the future. It’s part of the careful process of developing new medicines to help people with cancer.

Key takeaways

This study is testing a new cancer medicine, CT7439, for solid tumours.
It's an early-stage study focused on safety and finding the best dose.
Participants will initially take CT7439 capsules by themselves.
A team of doctors will closely monitor participants' health throughout.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, people need to have a confirmed diagnosis of a solid tumour. Doctors will check your medical history to make sure you're well enough for the trial, for example, by looking at your overall health and how active you are. You also need to be able to take medicines by mouth and agree to follow all the study's instructions, including attending appointments and providing information.

For women, if you could potentially become pregnant, you must agree to use reliable contraception throughout the study and for at least 33 days after your last dose. If you're male and sexually active, you must use condoms and agree not to donate sperm during the study and for at least 93 days after your last dose. All participants should also be expected to live for at least three more months, in the opinion of the study doctor.

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.

Do I have a confirmed solid tumour?
Am I generally well enough to participate in a study, as assessed by a doctor?
Can I take medicines by mouth?
Am I willing to attend regular hospital visits and have tests?
If I am a woman, can I use reliable contraception if I could become pregnant?
If I am a man, am I willing to use condoms during the study and not donate sperm?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be taking CT7439 capsules. The dose will be carefully chosen by the study team, starting low and increasing gradually in different groups of people. You’ll continue taking the medicine for as long as it seems to be helping you, unless you experience side effects that are too difficult to manage, or your cancer starts to get worse. You also have the right to stop participating at any time.

Throughout the study, you'll have regular hospital visits. During these visits, the doctors and nurses will check your health, ask how you're feeling, and do tests like blood samples. They will also need access to your past medical records, including details about your cancer diagnosis and previous scans. The study team will closely monitor you to make sure the medicine is safe and to see how your body is responding. The total length of your participation will depend on how you respond to the treatment and your individual circumstances.

Potential risks and benefits

Participating in a clinical trial like this means you might be one of the first people to receive a new medication, which could potentially offer a benefit if existing treatments haven't worked well for you. However, there are also risks. New medicines can have side effects that doctors don't fully know about yet. These could be mild, like feeling tired, or more serious. The study team will monitor you very closely for any side effects and will explain all known risks before you decide to join. Remember, you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

Research site 03
Verified postcode
Dallas, United States· Recruiting
Research site 01
Verified postcode
San Antonio, United States· Recruiting
Research site 02
Verified postcode
Fairfax, United States· Recruiting
Research site 05
Verified postcode
Manchester, United Kingdom· Recruiting
Research site 04
Verified postcode
Oxford, United Kingdom· Recruiting
Research site 06
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that forms in the body, which is a common type of cancer, unlike blood cancers like leukaemia.

What does 'Phase 1/2' mean for a study?

This means it's an early stage of testing. Phase 1 focuses on safety and finding the right dose, and Phase 2 looks at how well the medicine works and more about its safety.

What is CT7439?

CT7439 is a new investigational medication being tested in this study. It comes in capsule form.

Will I get other cancer treatments during this study?

Initially, you'll receive CT7439 by itself. Later, if the study plan changes and is approved, it might be given alongside other cancer treatments.

How long will I be in the study?

You'll continue taking the medicine as long as it's helping and not causing too many problems, or until you choose to stop.

How to find out more

Clinical Operations

hello@carricktherapeutics.com +353 1 5996873 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.