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

A Phase 1, open-label, multiple-ascending dose study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of KD033 (SAR445710) in subjects with metastatic or locally advanced solid tumors

This important early-stage clinical trial is investigating a new medicine called KD033 (also known as SAR445710) for people living with advanced solid cancers that have spread or are difficult to treat. It's a 'Phase 1' study, which means it's one of the first times this medicine is being given to humans. The main goals are to carefully check its safety, understand how the body handles the medicine, and see if there are any early hints that it could be effective against cancer. Researchers will start with small doses and gradually increase them, all while closely monitoring for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Kadmon Corporation LLC

Enrolment target

Start

18 Jul 2023

Cancer

What is this study about?

You might have heard about clinical trials, which are research studies that test new ways to prevent, detect, or treat diseases like cancer. This particular study is in its very first stage, called Phase 1. This means the new medicine, KD033, is being given to people for the first time. The main aim isn't to cure cancer yet, but to gather essential information about the medicine itself. Think of it like taking the first careful steps with a new treatment.

The researchers want to understand several key things. Firstly, and most importantly, they need to see if KD033 is safe. This involves carefully looking for any side effects, particularly if they are serious. They will start with a very small dose and slowly increase it for different groups of participants, all while closely checking their health.

Secondly, they want to understand how the medicine behaves in the body – how it's absorbed, distributed, processed, and eventually leaves the body. This is crucial for working out the best and safest dose for future studies. Lastly, while safety is the main focus, they will also be looking for any early signs that the medicine might be affecting the cancer. This information helps them decide if the medicine is promising enough to move on to larger and more advanced trials in the future.

Key takeaways

This is a very early study of a new medicine for advanced solid cancers.
The main goals are to check the medicine's safety and how the body uses it.
Researchers will also look for any early signs that the medicine might be effective.
Participation involves regular clinic visits for checks, tests, and scans.
You'll be closely monitored for any side effects.

Who may be eligible?

To be able to join this study, generally, you'll need to be an adult, aged 18 or older. The study is open to both men and women.

The specific type of cancer being studied is 'metastatic or locally advanced solid tumors.' This means you would have a solid cancer (not a blood cancer) that has spread to other parts of the body (metastatic) or is in an advanced stage locally and cannot be treated with surgery.

There will be other important health checks to make sure the study is safe for you, such as your general health, how well your organs are working, and any other medical conditions you might have. These details would be thoroughly discussed with you by the study team.

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 'solid tumor' cancer (not a blood cancer)?
Has your cancer spread or is it locally advanced and not treatable by surgery?
Are you able to attend regular clinic visits and appointments?
Are you willing for doctors to closely monitor your health and any side effects?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the study medicine, KD033. This trial involves a careful process of increasing the dose over time for different groups of people. You would have regular visits to the clinic for various checks. These would include blood tests to see how the medicine is affecting your body and how your body is handling the medicine.

You would also have regular scans to monitor your cancer and see if the medicine is having any effect. The study team will closely monitor you for any side effects, and you'll be encouraged to report any changes in how you feel. The total length of your participation would be discussed with you, but typically, early-stage trials like this can involve multiple visits over several months.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new medicine before it's widely available, and close monitoring by medical experts. However, there are also potential risks, as KD033 is a new medicine and its full effects aren't yet known. You might experience side effects, some of which could be serious. The study team will explain all known risks and closely monitor your health. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
France
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Unverified
Spain

Common questions

What does 'Phase 1' mean?

Phase 1 means this is one of the very first studies where a new medicine is given to people. The main aim is to check its safety and how the body handles it.

Will this medicine cure my cancer?

The primary goal of this early-stage study isn't to cure cancer, but to understand if the new medicine is safe and if there are any early signs it might be working. Further studies would be needed to see if it can cure cancer.

What kind of cancer is this study for?

This study is for people with solid cancers that have spread to other parts of the body or are advanced and can't be removed by surgery.

What are 'side effects'?

Side effects are unwanted or unexpected effects caused by a medicine. The study team will carefully monitor you for any side effects and help manage them.

Can I leave the study once I've started?

Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.