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Study on the Safety and Tolerability of ODM-212 for Patients with Advanced Solid Tumors
Verified siteInvestigational
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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 focused on studying the effects of a new medication called ODM-212 in individuals with certain types of advanced solid tumors. Solid tumors are abnormal masses of tissue that can be either benign (non-cancerous) or malignant (cancerous). The study aims to evaluate the safety and tolerability of ODM-212 when taken orally in tablet form. The medication is being tested in two different doses: 5 mg and 40 mg tablets.
The purpose of the study is to understand how ODM-212 affects people with advanced solid tumors, particularly those with specific genetic changes that might make them more responsive to this treatment. These genetic changes involve alterations in the NF2, LATS1, LATS2 genes, or fusions involving YAP and TAZ. The study is divided into two parts. In the first part, researchers will focus on determining the safety and how well the body tolerates the medication. In the second part, they will continue to assess safety and gather more information on how the medication works in the body.
Participants in the study will receive either the 5 mg or 40 mg dose of ODM-212 and will be monitored for any side effects or changes in their condition. The study will also involve regular health assessments, including physical exams and laboratory tests, to ensure the safety of the participants. The trial is expected to continue until 2027, providing valuable insights into the potential benefits and risks of ODM-212 for treating advanced solid tumors.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- Participants must be male or female and 18 years or older.
- Participants must have a confirmed diagnosis of an advanced or spreading solid tumor. This includes specific genetic changes in the tumor, such as loss-of-function in certain genes or fusions in others. In Part 2, any solid tumor that might respond to a specific type of treatment based on previous data is included.
- Participants must need systemic treatment for their cancer. This means treatment that affects the whole body. They should have tried other treatments that didn't work, or they can't take them for some reason, according to the doctor's opinion.
- For Part 2 only: Participants must have a measurable disease using specific criteria for evaluating tumors.
- For Part 2 only: A recent tissue sample from the tumor must be available. This can be from a biopsy or surgery. Exceptions can be made by the study sponsor.
- Participants must have a performance status of 0-1 on a scale that measures how well they can carry out daily activities.
- Participants must have a life expectancy of more than 12 weeks.
- Participants must be willing and able to follow all parts of the study plan.
- Participants must provide written informed consent before any study-specific procedures begin. This means they agree to participate after understanding the study details.
Who cannot join the trial?
2 criteria
- Patients with certain types of cancer cannot participate. This includes both benign (non-cancerous) and malignant (cancerous) tumors, as well as cysts (fluid-filled sacs) and polyps (growths that can develop in various parts of the body).
- Patients who are part of a vulnerable population are excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Verified sites
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Verified Verified Centre Hospitalier Universitaire De Lille
Lille, FranceVerified Centre Oscar Lambret
Lille, France
Trial locations
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Investigated drugs
ODM-212 is a new medication being tested for its safety and how well people can tolerate it. It is taken by mouth and is being studied in people with certain advanced solid tumors. The trial aims to understand how this medication works on its own in treating these types of cancer.
What is already known about the treatment
ODM-212 – This medication is administered orally and is currently being studied in clinical trials for its safety and tolerability in patients with advanced solid tumors. It is in the early stages of research, specifically a first-in-human study, and is not yet widely recognized in medical literature. The main therapeutic indication for ODM-212 is the treatment of various types of tumors, including benign and malignant neoplasms. At the molecular level, ODM-212 works by targeting specific pathways involved in tumor growth, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational anti-cancer agent.
Investigated diseases
Neoplasms – Neoplasms, also known as tumors, are abnormal growths of tissue that can be benign (non-cancerous) or malignant (cancerous). Benign neoplasms grow slowly and do not spread to other parts of the body, while malignant neoplasms can invade nearby tissues and spread to distant sites. The progression of malignant neoplasms involves changes in the cells that lead to uncontrolled growth and the potential to metastasize. Neoplasms can occur in various parts of the body and may cause symptoms depending on their location and size. The development of neoplasms is influenced by genetic and environmental factors. Understanding the nature of a neoplasm is crucial for determining the appropriate management approach.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-503061-29-00Protocol code3134001Estimated enrolment315 patientsSponsorOrion Corporation
sourced from the EU Clinical Trials Register and site verification
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