Dose Escalation Study of OMX-0407 in patients with previously treated unresectable solid tumours.
Research type
Research Study
Full title
A Phase I Dose Escalation Study of OMX-0407 a Salt-inducible Kinase inhibitor in patients with previously treated unresectable solid tumours
IRAS ID
1006583
Contact name
Murray Yule
Contact email
Sponsor organisation
iOMX Therapeutics AG
Eudract number
2022-002245-18
Research summary
This study is funded by iOmx Therapeutics AG who are researching an investigational drug called OMX-0407 for the treatment of patients with advanced cancer who do not have a standard of care treatment option available. The word "investigational" means the product has not yet been approved in any country, including the UK Medicines and Healthcare products Regulatory Agency (MHRA) and is still being tested in research studies. This is the first study of OMX-0407 in humans. The main purpose of the study is to determine the safety of different doses of OMX-0407. The study will also evaluate how the drug is distributed and eliminated (exits) the human body. About 30-50 patients will join the study in Europe and the United Kingdom (UK). Patients will receive treatment every day for as long as they are benefiting from the treatment and the doctor considers that it is safe, for up to 24 cycles (28 days per cycle). Patients will attend visits more frequently during the first cycle and then on day 1 of each cycle afterwards. Assessments during the visits include blood draws, vital signs and an electrocardiogram (ECG). Additionally, there is imaging of the cancer every 12 weeks.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0015
Date of REC Opinion
30 Mar 2023
REC opinion
Further Information Unfavourable Opinion