TEADES
Research type
Research Study
Full title
TWO-PART, FIRST-IN-HUMAN STUDY ON ODM-212 IN SUBJECTS WITH SELECTED ADVANCED SOLID TUMOURS
IRAS ID
1008447
Contact name
Nadja Heimonen
Contact email
Sponsor organisation
Orion Corporation
Eudract number
2022-503061-29
ISRCTN Number
ISRCTN99739590
Research summary
ODM 212 is a new study medication that possibly inhibits biological processes which promote tumour cell growth.
The primary purpose of this study is to look at the safety of ODM-212 when given to participants who have locally advanced primary or recurrent cancer, or metastatic solid tumours.
This is a first-in-human study (the study medication has not been given to humans before). There are two parts to this study. 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. Participants enrolled in either part of the study will be on the study for approximately 14 months (up to 1 year on treatment), with the possibility of extension for an additional 1 year on treatment if deemed beneficial for them by the study doctor (the total duration of study approximately 26 months).
As ODM-212 is given to humans for the first time, it is unknown whether participants will benefit from taking ODM-212. This means that ODM-212 has not been approved for sale in any country.
This study plans on including approximately 213 study participants from approximately 30-35 study sites across Europe, North America and APAC (Australia). This study is sponsored by Orion Corporation.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0644
Date of REC Opinion
7 Nov 2023
REC opinion
Further Information Favourable Opinion