OncoMatch/Clinical Trials/NCT04923126
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
Is NCT04923126 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Mirdametinib for low-grade glioma.
Treatment: Mirdametinib — This is an open-label, multi-center, Phase 1/2 study of the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: BRAF fusion
BRAF fused or rearranged
Required: FGFR1 aberration
FGFR1/2/3 aberration
Required: FGFR2 aberration
FGFR1/2/3 aberration
Required: FGFR3 aberration
FGFR1/2/3 aberration
Required: NF1 mutation
NF1 mutation or germline mutation
Required: NF2 mutation
NF2 mutation or germline mutation
Required: PTPN11 mutation
PTPN11 mutation or germline mutation
Required: SOS1 mutation
SOS1 mutation or germline mutation
Required: RAF1 mutation
RAF1 mutation or germline mutation
Required: MYB fusion
MYB fused or rearranged
Required: MYBL1 fusion
MYBL1 fused or rearranged
Excluded: BRAF V600
BRAF V600 mutant
Excluded: NTRK1 fusion
NTRK1/2/3 fusion-positive
Excluded: NTRK2 fusion
NTRK1/2/3 fusion-positive
Excluded: NTRK3 fusion
NTRK1/2/3 fusion-positive
Excluded: ALK fusion
ALK fusion-positive
Excluded: ROS1 fusion
ROS1 fusion-positive
Excluded: IDH1 mutation
IDH 1/2 mutant
Excluded: IDH2 mutation
IDH 1/2 mutant
Excluded: H3F3A (H3 K27M) K27M
Histone H3 K27M/K28M or G34/G35-mutant
Excluded: HIST1H3B K27M
Histone H3 K27M/K28M or G34/G35-mutant
Disease stage
Excluded: Stage HIGH-GRADE (WHO III OR IV)
Grade: Low-grade (WHO)
Low-grade glioma; measurable or evaluable disease required
Prior therapy
Cannot have received: MEK inhibitor (mirdametinib)
Exception: Cohort 3A and 3B allow prior MEK inhibitor exposure with specific conditions
Patients must not have received prior exposure to any MEK inhibitors (except as allowed in Cohort 3A/3B)
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L without growth factor support within 7 days; Platelet count ≥ 75 x 10^9/L without platelet transfusion within 7 days; Hemoglobin ≥8.0 g/dL without blood transfusion within 7 days
Kidney function
Serum creatinine ≤ maximum based on age/gender (see protocol table)
Liver function
ALT and AST ≤ 2.5 x ULN (ULN = 45 U/L); total bilirubin ≤ ULN or if > ULN then direct bilirubin ≤ 1.5 x ULN
Cardiac function
LVEF > 50% by ECHO; QTc interval ≤ 450 msec (male), ≤ 470 msec (female) after electrolytes corrected
Adequate bone marrow and organ function as defined as: ... see protocol for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Jude Children's Research Hospital · Memphis, Tennessee
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