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

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What is this study about?

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.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of cancer, and previous treatments.

Written consent is required before any study-specific procedures begin.

2 initial assessment

An initial assessment is conducted to evaluate overall health and cancer status. This includes laboratory tests, physical examinations, and other safety assessments.

3 medication administration

The medication ODM-212 is administered orally in tablet form. Two dosages are used: 40 mg and 5 mg.

The frequency and duration of administration are determined by the study protocol and adjusted based on individual response and tolerance.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effects of the medication. This includes checking for any side effects and evaluating the response of the cancer to the treatment.

Follow-up assessments include laboratory tests, physical examinations, and imaging studies as needed.

5 evaluation of treatment response

The response to treatment is evaluated using criteria such as the Response Evaluation Criteria in Solid Tumours (RECIST). This involves measuring changes in tumor size and assessing overall health status.

The study aims to determine the safety and effectiveness of ODM-212 in treating advanced solid tumors.

6 completion of study participation

Participation in the study continues until the end of the trial or until it is determined that the treatment is no longer beneficial.

A final assessment is conducted to gather data on the long-term effects and overall outcomes of the treatment.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Turku University Hospital	Turku	Finland
Hospital Universitario 12 De Octubre	Madrid	Spain
Oulu University Hospital	Oulu	Finland
Hfepjxrq Unsphqopkz Czwyneo Hecxzbse	Helsinki	Finland
Heviydqo Vcls djjhryqa	Barcelona	Spain
Cfqvyk Olgwr Laavjpa	Lille	France

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	09.11.2023
France	Recruiting	09.11.2023
Spain	Recruiting	09.11.2023

Trial locations

Investigated drugs:

Odm-212

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.

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 ID:

2022-503061-29-00

Protocol code:

3134001

NCT ID:

NCT06725758

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

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