TEADCO
Research type
Research Study
Full title
A 2-PART PHASE 1/2 OPEN-LABEL TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ODM-212 IN COMBINATION WITH ANTI-CANCER THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMOURS
IRAS ID
1013597
Contact name
Jutta Hänninen
Contact email
Sponsor organisation
Orion Corporation
Research summary
- Advanced solid tumours are cancers that have spread from where they started or grown deeply into surrounding tissues. These tumours often resist initial treatments and are more difficult to manage.
- Current treatments combine traditional methods like surgery, chemotherapy, and radiation with newer targeted therapies.
- This study will test an experimental drug called ODM-212 alongside existing cancer treatments.
- ODM-212 is a new medication that blocks signals helping tumour cells grow. The sponsor believes ODM-212 could work against various cancer types. While tested in animals, there's limited human experience with this drug.
- The study has two parts. Part 1 determines if ODM-212 combined with other cancer treatments is safe and well-tolerated. In part 2, the main goal is to see what dose of ODM-212 in combination with other anti-cancer therapy is safe, tolerable and effective in treating participants with cancer.
- Part 1 includes three treatment groups, each testing ODM-212 with a different cancer therapy. The main goal is finding a safe, well-tolerated ODM-212 dose for Part 2. Researchers will also study how the body absorbs, processes, and eliminates ODM-212 and other cancer therapies. Additionally, they will assess how ODM-212 combined with other treatments affects the body.
- Participants will take ODM-212 tablets by mouth. Their participation will continue as long as they benefit from treatment without safety concerns.
- Planned enrollment is up to 69 participants for part 1 and 160 for part 2 across approximately 35 sites in Europe, the UK, and USA.
- Orion Corporation sponsors this study.REC name
London - Central Research Ethics Committee
REC reference
26/LO/0186
Date of REC Opinion
2 Apr 2026
REC opinion
Further Information Favourable Opinion