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AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A phase I/II trial of IOMX-0675 a fully human monoclonal antibody selectively inhibiting LILRB1/2 alone or in combination with pembrolizumab in patients with previously treated advanced/metastatic solid tumors (LIMNOS)

This research study is looking at a new medicine called IOMX-0675, either on its own or together with another common cancer drug called Keytruda. We want to understand how safe these treatments are and if they can help people with advanced cancers that have been treated before. The study will pay close attention to any side effects patients might experience and how the new drug moves through the body. We'll also be watching to see if the treatment helps shrink tumors or stop them from growing. This is an early-stage study, meaning it's one of the first times this new drug is being tested in people.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
iOmx Therapeutics AG
Enrolment target
110
Start
03 Apr 2025

What is this study about?

This research is looking into a new experimental medicine called IOMX-0675. This drug is designed to work with your body's own immune system to fight cancer. In this study, we're trying to find the best dose of IOMX-0675, both when it's given alone and when it's combined with another treatment you might have heard of, called Keytruda. Keytruda is already approved for certain cancers and also works by helping your immune system.

The main purpose of this study is to find a safe and effective dose. This involves carefully looking at any side effects people experience and understanding how the new drug behaves in the body. We call these 'Phase I' studies, and they are crucial for making sure a new medicine is safe before it can be studied in more people. After we find a safe dose, we'll also start looking at how well the treatment works against the cancer.

We will be checking if tumors shrink or stop growing, and how long people respond to the treatment. This kind of research helps doctors understand if a new medicine has the potential to become a future treatment option for people with advanced cancers that have already been treated with other medicines.

Key takeaways

  • This is an early-stage study testing a new drug for advanced cancers.
  • It's for people whose cancer has been treated before.
  • The study aims to find a safe dose and see how well the new drug works, alone or with Keytruda.
  • Regular monitoring for side effects and cancer progression will be part of the study.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for adults, aged 18 and over, who have advanced or metastatic solid cancers. 'Advanced' or 'metastatic' means the cancer has spread from where it started to other parts of the body.

Crucially, you must have already received treatment for your cancer in the past. This study is not for people who are being treated for the very first time.

Both men and women can take part. There will be other specific medical requirements that your doctor will need to check to make sure the study is right for you and safe for you to participate in.

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.

  1. Are you 18 years old or older?
  2. Do you have a solid cancer that is advanced or has spread?
  3. Have you already received treatment for your cancer in the past?
  4. Are you generally able to travel to a clinic for regular appointments and treatments?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and the cancer. You will receive the study medication, which will be either IOMX-0675 alone or IOMX-0675 combined with Keytruda, given as an infusion into your vein. The schedule for these infusions and other assessments will be explained in detail by the study team.

The study also involves careful monitoring for any side effects you might experience. You'll be asked to report how you're feeling regularly. The exact total duration of your participation will depend on how you respond to the treatment and your health, but there will also be follow-up appointments after you stop receiving the treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which might be beneficial if other treatments haven't worked for you. However, there are also risks. New treatments can cause unexpected side effects, and there's no guarantee that the treatment will work for your specific cancer. The study team will carefully monitor you for any problems. You 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.
  • Unverified
    Spain

Common questions

What does 'advanced/metastatic' mean?

It means the cancer has grown or spread from its original place to other parts of your body.

What is IOMX-0675?

It's a new experimental medicine being tested in this study. It's designed to help your immune system fight cancer.

What is Keytruda?

Keytruda is an existing cancer treatment that also works with your immune system. It's called pembrolizumab generally.

What is a 'Phase I' study?

This is an early stage of research where doctors first test a new medicine in people to check its safety and find the right dose.

Will this treatment cure my cancer?

It's too early to say if this treatment will cure cancer. The main goal of this study is to find a safe dose and see if it helps patients.

How to find out more

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

Discussion

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