Aalborg University Hospital
Aalborg, Denmark
Recruiting
Study of ODM-212 in Combination with Cancer Treatment for Patients with Advanced Solid Tumours
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- 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 trial?
29 criteria
- 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.
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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.
What is already known about the treatment
Paclitaxel albumin-bound
Paclitaxel albumin-bound is given by intravenous infusion, meaning it is delivered directly into a vein by a healthcare professional. It is a well-known cancer medicine used to treat several solid tumors, such as breast, lung, and pancreatic cancer, and it remains an important drug in medical practice and research. It works by stopping cancer cells from dividing normally, because it blocks the cell structures needed for cell growth and also uses albumin to help carry the medicine to the tumor.
Nivolumab
Nivolumab is given by intravenous infusion in a hospital or clinic setting. It is a widely used cancer immunotherapy that is well established in medical literature and is approved for several types of cancer, including lung cancer, melanoma, kidney cancer, and some others. It is a monoclonal antibody that blocks the PD-1 protein on immune cells, which helps the immune system recognize and attack cancer cells more strongly.
Gemcitabine
Gemcitabine is administered by intravenous infusion under medical supervision. It is a standard chemotherapy medicine with long-standing use in cancer treatment, especially for pancreatic cancer, lung cancer, bladder cancer, and some other solid tumors. It works by entering cancer cells and interfering with DNA building, which slows or stops cell division and leads to cell death.
Ipilimumab
Ipilimumab is given by intravenous infusion in a clinic or hospital. It is a well-known immune-based cancer treatment that is widely described in medical literature and is used for several cancers, including melanoma and some lung cancers. It is a monoclonal antibody that blocks CTLA-4, a brake on the immune system, so immune cells can become more active against cancer cells.
Sotorasib
Sotorasib is taken by mouth as an oral medicine. It is a newer targeted cancer drug that is now established in medical practice and literature, mainly for cancers with a KRAS G12C change, especially some non-small cell lung cancers and colorectal cancers. It works by attaching to the changed KRAS protein and turning off a signal that helps cancer cells grow and survive, so it is classified as a targeted anticancer therapy.
ODM-212
ODM-212 is given by mouth as a coated tablet, which means it is swallowed whole. It is an experimental medicine and is still being studied in clinical trials, so its full place in medicine is not yet known. Based on the trial setting, it is intended for use in advanced solid tumors and appears to be a targeted anticancer drug that works by blocking a specific signal inside cancer cells, a method used to slow tumor growth.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524620-22-00Protocol code3134003Estimated enrolment153 patientsSponsorOrion Corporation
sourced from the EU Clinical Trials Register and site verification
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