Study of ODM-212 in Combination with Cancer Treatment for Patients with Advanced Solid Tumours

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What is this study about?

This clinical trial is studying people with advanced solid tumors, which are cancers that form a lump or mass in the body, and it is testing ODM-212 together with standard cancer treatments. The other treatments used in the study are paclitaxel albumin-bound, nivolumab, gemcitabine, ipilimumab, and sotorasib. ODM-212 is given as a tablet by mouth, while the other medicines are given through a vein.

The purpose of the study is to find out whether ODM-212 can be given safely with these cancer treatments and what dose may be suitable. The study has 2 parts. In the first part, small groups of participants receive ODM-212 with one of the cancer treatments so that the study team can learn about side effects and choose a dose for the next part. In the second part, more participants receive the chosen dose together with the cancer treatment and are followed over time to see how the treatment is tolerated.

During the study, health checks, blood tests, and heart tests such as an ECG are done to watch for side effects and other changes in the body. The study also looks at how ODM-212 moves through the body and how much of it is present in the blood after treatment.

1 start of trial treatment

When you join the trial, you start ODM-212 together with one of the listed anti-cancer treatments. ODM-212 is taken by mouth as a coated tablet. The trial includes two tablet strengths: 5 mg and 40 mg. The exact dose and schedule are not stated in the source information.

The anti-cancer treatment used with ODM-212 may be one of the following: paclitaxel albumin-bound, nivolumab, gemcitabine, ipilimumab, or sotorasib. Paclitaxel albumin-bound, nivolumab, gemcitabine, and ipilimumab are given by intravenous administration, which means they are given through a vein. Sotorasib is taken by mouth.

2 part 1 treatment period

In part 1, you receive ODM-212 with anti-cancer treatment so that the study team can assess safety and tolerability. Tolerability means how well you can take the treatment and whether side effects are manageable.

During this part, the study team checks for dose-limiting toxicities, which are side effects serious enough to limit the dose, as well as other treatment-emergent adverse events, which are unwanted effects that start or get worse after treatment begins. The study team also checks for serious adverse events, which are severe unwanted effects, and for changes in clinical laboratory tests and electrocardiogram results. An electrocardiogram (ECG) is a test that records the heart’s electrical activity.

The results from part 1 are used to determine the recommended dose for part 2.

3 part 1 assessments of treatment effect

In part 1, the effect of treatment is also measured using RECIST version 1.1. RECIST is a standard way to measure whether tumours shrink, stay the same, or grow.

The study looks at objective response rate (ORR), which means the number of people whose tumours shrink enough to count as a response; duration of response (DOR), which means how long that response lasts; disease control rate (DCR), which means the number of people whose disease shrinks or stays stable; progression-free survival (PFS), which means the length of time before the disease gets worse; and the duration of stable disease, which means how long the disease does not grow.

4 part 1 drug level testing

In part 1, the amount of ODM-212 in your body is measured on the last day of cycle 1 or cycle 2. A cycle is a treatment period used in the trial.

The study measures pharmacokinetics (PK), which means how the body absorbs, moves, and removes the medicine. The measurements include maximum concentration (Cmax), area under the curve to time t (AUCt), and area under the curve from 0 to 24 hours (AUC0-24).

5 part 2 treatment period

In part 2, you receive ODM-212 with anti-cancer treatment using the dose selected from part 1. The main purpose of this part is to check safety and tolerability again with the selected dose.

The study team checks for treatment-emergent adverse events, serious adverse events, and changes in clinical laboratory tests and electrocardiogram results.

6 part 2 assessments of treatment effect

In part 2, the study also measures how well treatment works using RECIST version 1.1. The outcomes include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS). Overall survival (OS) means the length of time from the start of treatment until death from any cause.

The study also uses the available safety, exposure, and other nonclinical, clinical, pharmacokinetic, and biomarker data to support dose selection. A biomarker is a measurable sign in the body that can give information about a disease or treatment.

7 part 2 drug level testing

In part 2, the amount of ODM-212 in your body is measured on the last day of cycle 1.

The study measures pharmacokinetics (PK), including maximum concentration (Cmax), area under the curve to time t (AUCt), and area under the curve from 0 to 24 hours (AUC0-24).

Who Can Join the Study?

Be willing to sign a written informed consent, which means agreeing in writing to take part before any study tests are done. If needed, a witness may also sign.
Be able to have paired fresh tumor biopsies, meaning two small tissue samples taken from the tumor: one during the screening period and one during treatment. The sponsor may allow exceptions.
Be willing and able to follow all parts of the study plan.
Be a male or female adult, aged 18 years or older.
Have an ECOG performance status of 0 to 1. This is a scale that shows how active a person is in daily life; 0 means fully active, and 1 means some symptoms but still able to do light work.
Have a life expectancy of more than 12 weeks, according to the study doctor.
Be able to take oral medication, meaning medicine by mouth, and be willing to record daily whether the study medicine was taken.
Have a confirmed advanced or metastatic, unresectable solid tumor. This means a solid cancer that has been proven by tissue or cells, is advanced or has spread, and cannot be removed by surgery.
Be able and willing to receive one of the anti-cancer treatments being studied, as decided by the study doctor.
For Part 2 only, have measurable disease by RECIST 1.1, which means the tumors must be large enough to be measured on scans using a standard cancer measurement system.
Have a recent tumor tissue sample available, taken within the last 1 year, from the main tumor or from a metastasis, which is a place where the cancer has spread.
The tumor tissue sample must come from a core needle biopsy, excisional biopsy, or incisional biopsy. A core needle biopsy uses a needle to remove a small tissue sample, an excisional biopsy removes the whole lump or area, and an incisional biopsy removes part of it.

Who Cannot Join the Study?

Having another active cancer within the past 2 years, except for certain treated skin cancers, superficial bladder cancer, or early cancers of the cervix or breast that have already had curative treatment.
Being unable to take medicine by mouth, or having a malabsorption syndrome (a condition where the body does not absorb nutrients or medicine properly), or another uncontrolled stomach or bowel problem such as nausea, diarrhea, or vomiting that could stop the study drug from being absorbed properly.
Using another investigational medicine (a study drug not yet approved for general use) within 2 weeks before the trial, or within at least 5 half-lives of that drug, whichever is longer. For some investigational antibody drugs, at least 8 weeks are required. Any unresolved side effects from that prior treatment that could be unsafe also exclude participation.
Having received any live or live-attenuated vaccine (a vaccine made with a weakened germ) within 28 days before the first study dose, such as nasal flu vaccine, measles, mumps, rubella, shingles, oral polio, BCG, yellow fever, varicella, or TY21a typhoid vaccine.
Having important problems on the heart tracing test called an ECG (electrocardiogram), such as certain heart block problems, a very long QT interval (a measure of heart electrical timing), or other serious rhythm or conduction problems.
Having a history or risk of torsade de pointes (a dangerous abnormal heart rhythm), such as heart failure, low potassium, a family history of long QT syndrome, or taking medicines known to cause this rhythm problem.
Having serious heart or blood vessel problems, such as severe heart failure, uncontrolled high blood pressure, unstable chest pain, past heart attack, past stroke, heart pumping function below 50%, or a heart rhythm problem that needed treatment within the last 6 months.
Being pregnant or breastfeeding at screening or at the start of the trial.
Being a woman who could become pregnant and had unprotected sex within 30 days before joining, or who does not agree to use a highly effective birth control method during the study and for the required time after it.
Being a woman who could become pregnant and is not currently abstinent or does not agree to avoid sexual activity during the study and for the required time after it, if required by the protocol.
Being a woman using hormonal birth control but not on a stable dose of the same product for at least 4 weeks before dosing, unless she agrees to also use a barrier method such as a condom during the study and afterward as required.
Being a man who does not agree to use acceptable birth control during the study and for the required time after it, if his partner can become pregnant.
Being a man who does not agree not to donate sperm during the study and for the required time after it.
Having kidney function that is at least moderately reduced, shown by an eGFR below 60 ml/min. eGFR is a blood test estimate of how well the kidneys filter waste.
Having liver problems based on screening blood tests, such as bilirubin at least 1.5 times normal, AST or ALT more than 3 times normal, or low albumin. Bilirubin, AST, ALT, and albumin are blood tests that show how well the liver is working.
Having had anti-cancer treatment within less than 2 weeks before the first study dose.
Having abnormal clotting test results, with INR above 1.5 times normal, unless the person is taking blood thinners and the result is in the intended treatment range.
Having low blood counts: hemoglobin below 9 g/dl, neutrophils below 1500/µl, or platelets below 100,000/µl. Hemoglobin carries oxygen, neutrophils help fight infection, and platelets help blood clot.
Having any other major illness or medical condition that, in the investigator’s judgment, would make the trial too risky or make participation difficult.
Having a known allergy or sensitivity to any product used during dosing.
Having any condition that makes the planned treatment unsafe, including active or severe autoimmune disease (a condition where the immune system attacks the body), a history of colitis (colon inflammation), hepatitis (liver inflammation), pneumonitis (lung inflammation), interstitial lung disease, or severe lung scarring called pulmonary fibrosis.
Having ever been treated with another TEAD inhibitor (a medicine that blocks a specific cancer-related protein).
Having side effects from earlier anti-cancer treatment that have not gone away and are grade 2 or higher, except for certain allowed problems such as peripheral neuropathy, hair loss, controlled hormone-related problems, or symptom-free lab changes.
Having had major radiation treatment within 4 weeks before the first study dose, or palliative radiation treatment within 2 weeks before the first study dose. Palliative radiation is treatment given to relieve symptoms rather than to cure.
Having brain or subdural metastases (cancer that has spread to the brain or to the space under the outer covering of the brain), unless these are without symptoms and have been treated locally.
Having a severe active infection within 1 week before joining the trial.
Having a known positive test for hepatitis B surface antigen, hepatitis C virus RNA, or known HIV infection. These are blood tests for hepatitis B, hepatitis C, and human immunodeficiency virus.
Having had major surgery within 4 weeks before the first study dose, or minor surgery within 1 week before it, unless recovery from surgery-related side effects is better than grade 2.
Using strong immunosuppressive medicines, such as steroids, within 2 days before the first study dose. Immunosuppressive medicines lower the activity of the immune system.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Turku University Hospital	Turku	Finland
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Hleoryim Uhzgahakdn Cozkpcs Hbipojjr	Helsinki	Finland
Hirnegac Vjrs dolpjpwn	Barcelona	Spain
Inskkeuw Cbvyvd Docxafeklhlhmadls	L'hospitalet De Llobregat	Spain
Aaerpmyeof Ppzfjtcs Hubycozj Dz Muiqnadip	Marseille	France

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	20.05.2026
Finland	Not yet recruiting	20.05.2026
France	Not yet recruiting	20.05.2026
Spain	Not yet recruiting	20.05.2026

Trial locations

Investigated drugs:

Paclitaxel albumin-bound is a chemotherapy medicine given through a vein. It is used to kill cancer cells or slow their growth. In this trial, it is one of the anti-cancer treatments being combined with the study medicine.

Nivolumab is an immunotherapy medicine given through a vein. It helps the body’s immune system find and attack cancer cells. In this trial, it is being tested together with the study medicine to see if the combination is safe and works well.

Gemcitabine is a chemotherapy medicine given through a vein. It works by stopping cancer cells from growing and dividing. In this trial, it is part of the anti-cancer treatment given with the study medicine.

Ipilimumab is an immunotherapy medicine given through a vein. It helps activate the immune system so it can better attack cancer cells. In this trial, it is being used in combination with the study medicine to assess safety and possible benefit.

Sotorasib is a cancer medicine taken by mouth. It targets a specific change in cancer cells to help slow or stop tumor growth. In this trial, it is one of the anti-cancer therapies combined with the study medicine.

ODM-212 is the study medicine being tested in this trial. It is taken by mouth as a coated tablet. Researchers are studying its safety, how the body handles it, and how well it may work when given with other anti-cancer treatments in people with advanced solid tumors.

Neoplasms – Neoplasms are abnormal growths of body tissue formed by cells that multiply in an uncontrolled way. They may be benign, malignant, or of uncertain behavior. Benign neoplasms usually grow slowly and stay in one place, while malignant neoplasms can invade nearby tissue and spread to other parts of the body. Some neoplasms remain stable for a long time, while others gradually enlarge or change over time.

Trial ID:

2025-524620-22-00

Protocol code:

3134003

NCT ID:

NCT07563738

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of ODM-212 in Combination with Cancer Treatment for Patients with Advanced Solid Tumours

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?