#1 Clinical Trials Search in Europe

Odm-212

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.

Table of Contents

What is ODM-212?

ODM-212 is a new medication currently being studied for the treatment of certain types of cancer[1]. 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[1]. 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[1]. 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[1].

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[1]. 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[1]:

  1. Dose escalation: Researchers start with a low dose of the drug and gradually increase it to find the safest and most effective dose.
  2. 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[1]. 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[1].
  • 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[1].

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[1]. This long-term follow-up helps researchers understand both the immediate and long-term effects of the drug.

Aspect Details
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)

FAQ

  • What is ODM-212? ODM-212 is a new drug being tested in clinical trials for patients with advanced solid tumors. It is administered in the form of 5mg and/or 40mg tablets.
  • What type of clinical trial is being conducted for ODM-212? The clinical trial for ODM-212 is a two-part, first-in-human study. It is a multi-site, open-label trial that includes a dose escalation phase and a dose expansion phase.
  • Who can participate in this clinical trial? The trial is designed for subjects with selected advanced solid tumors. Specific eligibility criteria would be determined by the study investigators.
  • What are the primary outcomes being measured in this trial? The primary outcomes include the incidence and frequency of treatment emergent adverse events (TEAEs), as well as the severity of these events. These will be monitored from the first dose up to 1 year after the last subject's last visit.
  • How will the safety of ODM-212 be evaluated? Safety will be evaluated by monitoring treatment emergent adverse events (TEAEs). These are any events that arise or worsen after the start of treatment until 28 days after the last treatment intake. The severity of these events will be graded according to standardized criteria.

Ongoing Clinical Trials on Odm-212

  • Study on the Safety and Tolerability of ODM-212 for Patients with Advanced Solid Tumors

    Recruiting

    2 1 1
    Investigated drugs:
    Finland France Spain

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

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Denmark Finland France Spain

Glossary

  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Dose escalation: A phase in a clinical trial where the dose of a drug is gradually increased to determine the optimal dose that balances effectiveness and safety.
  • Dose expansion: A phase in a clinical trial where the determined optimal dose is given to a larger group of participants to further evaluate its effects.
  • Solid tumors: Abnormal masses of tissue that usually do not contain cysts or liquid areas. Solid tumors may be benign or malignant.
  • Treatment emergent adverse events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that appears or worsens after a participant starts receiving the study treatment.
  • NCI CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events, a standardized system for grading the severity of adverse events in cancer therapy clinical trials.
  • Proteinuria: The presence of excess proteins in the urine, which may indicate kidney damage.
  • UACR: Urine Albumin/Creatinine Ratio, a test used to detect kidney damage by measuring the amount of albumin in urine compared to creatinine.
  • First-in-Human study: The first administration of a new drug or treatment to humans, typically healthy volunteers or patients, to evaluate its safety, tolerability, and sometimes early signs of efficacy.

References