OncoMatch/Clinical Trials/NCT04923126
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
Is NCT04923126 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04923126 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MEK inhibitor disqualifies patients from enrollment.
Does this trial require BRAF?
Yes, BRAF fusion is a required biomarker for enrollment.
Does this trial require FGFR1?
Yes, FGFR1 aberration is a required biomarker for enrollment.
Does this trial require FGFR2?
Yes, FGFR2 aberration is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF V600 is an exclusion criterion.
Are patients with NTRK1 alterations eligible?
No. NTRK1 fusion is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 24 years or younger and at least 2 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages