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| Diagnosis | Non-hematological tumours (solid and brain) with relevant biomarker | Study Status | Open |
| Phase | I/II |
| Age | 12 Years and older | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: DAY101 (Oral tablet)
Drug: Pimasertib Hydrochloride (Oral capsule) - Sub-study B only.
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| Last Posted Update | 2024-04-02 |
| ClinicalTrials.gov # | NCT04985604 |
International Sponsor
Day One Biopharmaceuticals, Inc.Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
This is a Phase 1b/2 study of the drug DAY101 in patients ≥12 years of age with solid tumours or brain tumours that have come back or progressed. This study includes 2 sub-studies, patients in sub-study A will receive the DAY-101 drug and patients in sub-study B will receive "DAY-101" and another drug called pimasertib in combination.
Inclusion Criteria
- Participants must be between 12 to 18 years old
- Participants must have a solid tumour or brain tumour that has come back (relapsed) or progressed
- Participants must have a qualifying gene change in the tumour (MAPK pathway)
- If enrolled on study, patients and their families must agree to the study requirements by signing an informed consent/assent form
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
