drugset / Trial / NCT07850635
A Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Phase 1
Not yet recruiting
6 enrolled
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety, pharmacokinetic (PK), and tolerability of multiple treatment cycles of oral mirdametinib in infants and toddlers (0 to less than \[\<\] 24 months of age) with measurable neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PNs) that is symptomatic or asymptomatic but in a high-risk location with a high risk of morbidity.
Timeline
- Start
- 2026-12-10
- Primary completion
- 2032-10-21
- Completion
- 2032-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirdametinib | Small molecule | 0.25 mg | Oral |
| Subject | Mirdametinib | Small molecule | 0.5 mg | Oral |