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

A Phase I/Ib Dose Escalation and Cohort Expansion Study of OMX-0407 a Salt-inducible Kinase inhibitor in patients with previously treated unresectable solid tumours

This study is for adults with advanced cancers that cannot be removed by surgery and have already received previous treatments. It's an early-stage clinical trial (Phase I/Ib) which means it's one of the first times this new medicine, called OMX-0407, is being tested in people. The main goals are to find a safe dose of OMX-0407 and to see if it can shrink or stop the growth of tumours. Researchers will carefully check how patients respond to the treatment over time using scans and other tests. This study will help us understand more about this new treatment and if it could be a helpful option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

iOmx Therapeutics AG

Enrolment target

224

Start

23 Sep 2024

Previously treated unresectable solid tumours

What is this study about?

This study is investigating a new medication called OMX-0407. This medicine works by targeting something specific in cancer cells, aiming to stop them from growing and spreading. It's for people who have solid tumours, which are types of cancer that form a lump, and whose cancer has advanced to a stage where it can't be removed by surgery. These patients have also received other treatments for their cancer in the past.

Because this is a very early stage (Phase I/Ib) study, the first part is about finding the safest dose of OMX-0407. Doctors will start with a small dose and gradually increase it, carefully watching for any side effects. Once a safe dose is found, more patients will join the study to see how effective the medicine is at treating their cancer. This involves regular checks to see if the tumours are shrinking or stable.

The information gathered from this study is really important. It helps doctors understand if OMX-0407 is safe enough and shows enough promise to be tested in larger studies in the future. The aim is to find new and better ways to treat advanced cancers when other treatments have already been tried.

Key takeaways

Tests a new medicine (OMX-0407) for advanced solid tumours.
For patients who have already had other treatments.
Early stage study to find a safe dose and see how well it works.
Involves regular check-ups and scans to monitor cancer changes.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You would be considered for this study if you have a type of cancer that forms a solid tumour and has spread or cannot be removed by surgery. Importantly, your cancer would have already been treated with other methods before.

There will be other health requirements that your doctors will need to check to make sure the study medicine is right and safe for you. These might include certain blood test results or how well your organs are working. It's important to discuss all your current health conditions and medicines with 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 type of cancer that forms a solid lump?
Has your cancer spread or cannot be removed by surgery?
Have you already received other treatments for your cancer?
Are you willing to have regular clinic visits and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the new medicine, OMX-0407. The first part of the study involves doctors carefully finding the right dose for everyone. You'll have regular visits to the clinic for check-ups, blood tests, and scans. These tests will help the doctors see how well the medicine is working and monitor for any side effects.

Your tumours will be measured at the start of the study and then every 12 weeks (about every three months) to see if they are responding to the treatment. If you have skin lesions, photos might be taken by independent experts to track changes. The study will continue for as long as you are benefiting from the treatment and are not having severe side effects. The total duration of your participation will depend on your individual response to the medication.

Potential risks and benefits

Taking part in this study means you could potentially benefit from a new treatment that might help control your cancer. However, as with any new medicine, there's always a chance of side effects, some of which might be serious or unexpected. These will be carefully monitored throughout the study. Remember, joining is completely voluntary, and you have the right 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
Belgium
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Unverified
Spain
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Unverified
France

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a mass or lump, unlike blood cancers like leukaemia.

What does 'unresectable' mean?

It means the cancer cannot be completely removed by surgery, often because of its size, location, or if it has spread.

What is 'Phase I/Ib'?

This is an early stage of testing new medicines in people. The main goals are to find a safe dose and see initial signs of effectiveness.

What are 'DLTs'?

DLTs stands for 'Dose-Limiting Toxicities.' These are side effects that are serious enough to limit how much of the drug can be given.

What does 'previously treated' mean?

It means you have already received other cancer treatments (like chemotherapy, radiotherapy, or immunotherapy) for your condition before joining this study.