In short
A groundbreaking clinical trial is underway to investigate the potential of ODM-212, a new drug being tested for patients with advanced solid tumors. This multi-site, open-label study aims to evaluate the safety and effectiveness of ODM-212 in two parts: dose escalation and dose expansion. The trial represents an important step in understanding how this novel treatment may benefit patients with difficult-to-treat solid tumors.
At a glance
- Study Type
- Two-part, First-in-Human, Multi-site, Open-label
- Study Drug
- ODM-212 (5mg and/or 40mg tablets)
- Target Population
- Subjects with selected advanced solid tumours
- Study Parts
- 1. Dose escalation; 2. Dose expansion
- Primary Outcomes
- 1. Incidence and frequency of TEAEs; 2. Severity of TEAEs
- Safety Evaluation
- Monitoring of TEAEs from first dose to 1 year after last subject's last visit
- Adverse Event Grading
- NCI CTCAE version 5.0 (except for proteinuria)
What is ODM-212?
ODM-212 is a new medication currently being studied for the treatment of certain types of cancer. It is considered a first-in-human drug, which means it is being tested in people for the first time after showing promising results in laboratory studies. This drug is still in the early stages of research, and scientists are working to understand how it affects the human body and whether it can effectively treat cancer.
What condition does ODM-212 treat?
ODM-212 is being developed to treat advanced solid tumors. Solid tumors are abnormal masses of tissue that don't contain cysts or liquid areas. They may occur in various parts of the body, such as the lungs, breast, colon, or prostate. The term "advanced" typically means that the cancer has spread from where it started to other parts of the body or is at a later stage.
Current Clinical Trial
ODM-212 is currently being studied in a clinical trial. This trial is described as a multi-site, open-label, first-in-human study. Let's break down what this means:
- Multi-site: The study is being conducted at multiple hospitals or research centers.
- Open-label: Both the researchers and the participants know which treatment is being given.
- First-in-human: This is the first time the drug is being tested in people.
The study has two parts:
- Dose escalation: Researchers start with a low dose of the drug and gradually increase it to find the safest and most effective dose.
- Dose expansion: Once the best dose is determined, more patients are given this dose to further study its effects.
How is ODM-212 administered?
ODM-212 is given to patients in the form of tablets. The study is using two different strengths of tablets: 5mg and 40mg. Depending on the dose a patient needs, they may take one or both types of tablets. The exact dosing schedule and how long patients will take the medication will be determined as part of the study.
Safety Monitoring
A crucial part of this clinical trial is monitoring the safety of ODM-212. Researchers are particularly interested in understanding any side effects that may occur. They will be looking at:
- Treatment Emergent Adverse Events (TEAEs): These are any new medical problems or worsening of existing problems that occur after a patient starts taking ODM-212. Researchers will track how often these events happen and how severe they are.
- Severity of side effects: Any side effects will be graded according to standardized criteria called the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This helps researchers understand how serious the side effects are.
Patients in the study will be monitored for side effects from the time they take their first dose until one year after the last patient in the study receives their last dose. This long-term follow-up helps researchers understand both the immediate and long-term effects of the drug.