A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
This research is a 'first-in-human' study for a new drug called ODM-212, designed for individuals with advanced solid cancers that have progressed or haven't responded to standard treatments. It's split into two parts: the first part will carefully increase the dose of ODM-212 to find a safe and effective amount. The second part will then use this dose in a larger group of people to see how well it works against specific cancer types, particularly those with certain genetic changes. The study is open to both men and women aged 18 and over, looking for new treatment options.
At a glance
What is this study about?
This study is looking at a new treatment called ODM-212 for people who have advanced solid cancers, which are cancers that have spread or haven't responded to previous treatments. It's a 'first-in-human' study, meaning this is one of the first times this drug is being tested in people. The main goal is to find out if ODM-212 is safe and what dose can be given without causing too many side effects.
The study is divided into two main stages. The first stage, called 'dose escalation', involves a small group of patients receiving different doses of ODM-212. Doctors will start with a very low dose and gradually increase it, closely monitoring patients to see how their bodies react and to identify the safest and most effective dose. The second stage, called 'dose expansion', will use the dose found in the first stage and give it to a larger group of patients with specific types of solid cancers. This will help researchers get a better idea of how well the drug works against these cancers.
The researchers are particularly interested in cancers that have certain genetic changes or come from specific tumour types that they believe might respond to this new drug. This research is important because it could potentially offer a new treatment option for people with advanced cancers who have limited choices left.
Key takeaways
- Tests a new drug (ODM-212) for advanced solid cancers.
- A 'first-in-human' study, so it's early stage research.
- Aims to find a safe dose and see if the drug works.
- For people whose cancer hasn't responded to other treatments.
- Participation involves regular hospital visits and monitoring.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. You must have a type of advanced solid cancer (cancer that has spread or come back) that doctors believe can't be cured with current treatments.
Crucially, your cancer should not be responding to existing treatments, or you might not be able to take those treatments for other reasons. For the second part of the study, your cancer needs to be measurable, meaning doctors can track its size, and they might need a recent tissue sample from your cancer.
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 or older?
- Do you have an advanced solid cancer that current treatments are no longer helping, or that you can't take?
- For the second part of the study, can your cancer be measured (e.g., on a scan)?
- For the second part of the study, is a recent tissue sample from your cancer available?
What does participation involve?
Taking part in this study would involve regular visits to the hospital for checks and to receive the study drug, ODM-212. During these visits, you would have medical exams, blood tests, and scans (if you're in the second part of the study) to see how the treatment is affecting you and your cancer. You would be given the study drug, ODM-212, as directed by the study doctors. The exact number of visits and the full duration of your participation would depend on how your body responds to the treatment and the stage of the study you are in. Throughout your time in the study, doctors and nurses will closely monitor your health.
Potential risks and benefits
Locations (20)
- Valkyrie Clinical TrialsVerified postcodeLos Angeles, United States· Recruiting
- UC Irvine HealthVerified postcodeOrange, United States· Recruiting
- Siteman Cancer CenterVerified postcodeSt Louis, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- Westchester Medical CenterVerified postcodeValhalla, United States· Recruiting
- Jefferson University HospitalVerified postcodePhiladelphia, United States· Recruiting
- University of Texas, MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- NEXT VirginiaVerified postcodeFairfax, United States· Recruiting
- Helsinki university HospitalVerified postcodeHelsinki, Finland· Recruiting
- Oulu University HospitalVerified postcodeOulu, Finland· Recruiting
- Turku University HospitalVerified postcodeTurku, Finland· Recruiting
- Institut BergonieVerified postcodeBordeaux, France· Recruiting
Common questions
What kind of cancers are included in this study?
This study is looking at various advanced solid cancers, including types like mesothelioma, liver cancer (cholangiocarcinoma, hepatocellular cancer), specific head and neck cancers, lung cancer, bowel cancer, and prostate cancer, especially if they have certain genetic changes.
What does 'advanced solid tumours' mean?
This refers to cancers that have spread from where they started or have returned after previous treatment, and current treatments are no longer effective or suitable.
What is ODM-212?
ODM-212 is a new drug being tested for the first time in people. This study aims to find out if it's safe and how well it works against certain cancers.
Will I know if the drug is working?
The study team will regularly perform tests, like scans and blood tests, to monitor your cancer and your overall health, and they will discuss these results with you.
Can I stop participating in the study at any time?
Yes, your participation is completely voluntary, and you can decide to leave the study at any point without it affecting your ongoing medical care.
How to find out more
Clinical Study Director
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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