Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An open-label, multi-center, dose-escalation Phase Ib study to determine the recommended phase 2 dose of APN401 in patients with advanced solid tumors

This research study is looking at a new treatment called APN401 for adults who have advanced cancers. It's an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving. The main goal is to carefully test different doses of APN401 to find the safest and most effective amount for future studies. This is an early-stage study, often called a Phase 1 study, which means it’s one of the first times this new medicine is being used in people. The researchers want to understand how it works in the body and if it has any side effects, and eventually help people living with cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Invios GmbH

Enrolment target

Start

24 Jul 2023

Adult patients with advanced solid tumors

What is this study about?

This study is for adults who have advanced solid tumours. "Solid tumours" are growths of abnormal cells in organs like the lung, breast, or colon, as opposed to blood cancers. "Advanced" means the cancer has grown or spread.

The new medicine being tested is called APN401. This is a very early study, sometimes called a "Phase 1" study, which means it’s one of the first times this particular medicine is being tested in people. The main purpose is to find the best and safest dose of APN401 to use in future, larger studies. Researchers will start with a small dose and gradually increase it, while carefully watching how people respond.

By taking part, you would be helping doctors learn more about this new treatment. This kind of research is very important for developing new ways to fight cancer in the future and could potentially offer a new treatment option for people like you.

Key takeaways

New medicine (APN401) for advanced cancers.
Early stage study to find the best dose.
Open to adults aged 18 and over.
Close monitoring and regular check-ups.
Helps advance cancer research for the future.
You can withdraw at any time.

Who may be eligible?

This study is looking for adults who have advanced solid tumours. This means your cancer would be in a later stage of growth or has spread from where it started.

You must be 18 years old or older to take part. The study is open to both men and women.

There might be other health requirements or previous treatments that would affect whether you can join, but your doctor can explain these in more detail.

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 an advanced solid tumour?
Are you willing to attend regular hospital visits?
Are you able to understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, APN401. It's an "open-label" study, which simply means everyone involved – you and your doctors – will know that you are receiving APN401. You would have regular visits to the hospital or clinic for check-ups, where doctors would carefully monitor how you are doing, how the medicine is affecting you, and if you experience any side effects. These visits would also involve various tests, such as blood tests or scans, to track the cancer and your overall health. The specific number of visits and the total length of time you'd be in the study would depend on how you respond to the treatment, but it would involve ongoing monitoring and follow-up.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. While there's no guarantee that APN401 will directly help your cancer, you might benefit from the close medical attention and monitoring you'd receive. You would also be contributing to important medical research that could help others in the future. Potential risks include side effects from the new medicine, which are not yet fully known, as well as the inconvenience of extra hospital visits and tests. You always have the right to 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
Austria

Common questions

What does 'advanced solid tumours' mean?

This means your cancer has either spread from where it started or has grown significantly within an organ.

What is a 'Phase 1' study?

It's an early-stage study where doctors are trying a new medicine in people for the first time to understand how it works and what doses are safe.

Will I know if I'm getting the study drug?

Yes, this is an 'open-label' study, so you and your doctor will both know you are receiving APN401.

How long will I be in the study?

The length of time you participate can vary depending on how you respond to the treatment, but it would involve ongoing visits and check-ups.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.