AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours

This research is looking into a new medicine, ODM-212, which will be given together with other anti-cancer drugs to people who have advanced solid tumours. It's split into two main parts. The first part focuses on understanding if the treatment is safe, what side effects might occur, and how the medicine moves through the body. The second part continues to monitor safety and also investigates if the treatment is effectively shrinking tumours, making them stable, or slowing their progress. The goal is to find out if this new combination treatment could be a helpful option for cancer patients, always making sure patient well-being is the top priority.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Orion Corporation

Enrolment target

Start

22 May 2026

Neoplasms benign malignant and unspecified (incl. cysts and polyps)

What is this study about?

This study is trying to find new ways to treat advanced solid tumours. These are cancers that have grown or spread in the body. We're looking at a new medicine called ODM-212. It will be given with other cancer treatments that are already available, like PACLITAXEL ALBUMIN-BOUND, NIVOLUMAB, GEMCITABINE, IPILIMUMAB, or SOTORASIB. The research is divided into two main stages, called Phase 1 and Phase 2, which will run together.

In the first stage, the main goal is to check how safe the new medicine is when combined with other treatments. The medical team will carefully watch for any side effects, which we call "adverse events." They'll also look at serious side effects and any changes in blood tests or heart readings (like an ECG). This helps them understand the right dose of ODM-212 and how your body processes the medicine.

Once we have a better idea of the safety, the second stage will continue to monitor side effects, but will also focus on how well the treatment works. This means looking to see if the tumours shrink, stay the same size, or stop growing. The team will measure things like how long people live without their cancer getting worse, and how many people see their tumours respond to the treatment. This helps us understand if ODM-212 could be a helpful new treatment option for people with advanced solid tumours.

Key takeaways

This study is testing a new cancer drug, ODM-212, with existing treatments.
It's for people with advanced solid tumours.
The main goals are to check safety and how well the treatment works.
Participation involves regular checks and tests.
You have the right to leave the study at any time.
Potential benefits include access to new treatment; risks include possible side effects.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. People of any gender can take part.

You would be considered if you have a type of advanced solid tumour. These are cancers that have grown or spread. This study is generally for people who have tried other treatments already, and their cancer is still progressing, or if they can't have other treatments.

There will be other detailed health checks to make sure the study treatment is suitable and safe for you. This often includes looking at your overall health, other medicines you are taking, and specific details about your cancer. Your doctor will be able to explain all the requirements.

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 an advanced solid tumour?
Are you able to attend regular hospital/clinic visits?
Are you willing to try a new medicine in combination with standard cancer treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking a new medicine called ODM-212, either as a 5 mg or 40 mg coated tablet, along with one of the standard cancer treatments. You'll have regular visits to the hospital or clinic. During these visits, doctors and nurses will do various checks, including physical exams, blood tests, and heart tests (ECGs).

These tests help the study team monitor your health, check for any side effects, and see how the medicine is working in your body. They'll also take measurements of your tumours to see if they are responding to the treatment. The exact number of visits, tests, and the total time you'll be in the study will depend on how your treatment is going and which part of the study you are in. You will have regular contact with the study team throughout your participation.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, which might improve your health or slow the progression of your condition. However, there are also potential risks; the new medicine, ODM-212, could cause side effects, some of which may be serious, and it might not work for everyone. The study team will monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

—
Unverified
Finland
—
Unverified
Denmark
—
Unverified
Spain
—
Unverified
France

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumours, which are cancers that have grown or spread in the body.

What is ODM-212?

ODM-212 is a new medicine being tested in combination with other existing cancer treatments to see if it can help treat advanced solid tumours.

Will I still receive my normal cancer treatment?

Yes, in this study, ODM-212 is given *in combination* with other anti-cancer therapies that are already established treatments.

What are the main things the study wants to find out?

The study primarily aims to understand if the combination treatment is safe, what side effects it might cause, and if it can shrink tumours or stop them from growing.

How long will I be in the study if I participate?

The duration of your participation will depend on how your treatment progresses and the study's design. The study team will provide more specific details if you are found eligible.