TEADES

A Phase 1/​2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours (e.g. EHE, Epithelioid hemangioendothelioma) (TEADES)

Agent: ODM-212
Phase I/II
Status Recruiting
Sponsor Orion Corporation, Orion Pharma

 

For further information please also consult https://clinicaltrials.gov/study/NCT06725758. 

This is a multi-center, open-label, first-in-human study with 2 parts in subjects with selected advanced solid tumours (e.g. epithelioid hemangioendothelioma (EHE))

In Part 1, participants will receive increasing doses of ODM-212 in groups. As long as the previous dose was tolerated well the next group of participants will receive a higher dose until a maximum, tolerated dose is reached (this is the dose that does not produce serious side effects).

In Part 2, a larger group of participants will receive the dose established in Part 1 to further study the safety of and the effect ODM-212 has on cancer.

 

WHO is the trial for?
  • Male or female patients, 18 years and older
  • Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour, e.g.
    • EHE (epithelioid hemangioendothelioma)
    • Other solid tumours with dysfunction in Hippo pathway. See other non-sarcoma subtypes here
  • No curative treatment available
  • Patients may be eligible if they require systemic treatment for their cancer and available standard therapies have either not worked, were not tolerated, or are not considered suitable for medical reasons.
  • ECOG performance status 0-1

Additional medical eligibility criteria apply and are reviewed by the study team.

 

WHAT is the key question that this trial is attempting to answer?

 Which dose of ODM-212 is feasible and safe? Are there early signs of clinical activity?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in the US, Finland, France, Spain, Switzerland and United Kingdom.

For further information check here.

Study Contact:

Name: Clinical Study Director
Phone Number: +358104261
Email: clinicaltrials@orionpharma.com

STUDY DESIGN: What does the study look like?

 Open label design.
Drug: ODM-212, 5 mg, and / or 40 mg tablets
In Part 1, participants will receive increasing doses of ODM-212 in groups.
In Part 2, a larger group of participants will receive the dose established in Part 1 to further study the safety of ODM-212 and its effect on cancer.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken