Actively Recruiting
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
Led by St. Jude Children's Research Hospital · Updated on 2026-02-04
132
Participants Needed
1
Research Sites
518 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
S
SpringWorks Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have histologically confirmed or suspected low-grade glioma including neuronal and mixed neuronal-glial tumors
- Participant must have adequate tumor tissue for central pathology review
- Age must be 2 years or older and less than 25 years at enrollment
- Participant's body surface area (BSA) must meet protocol requirements for dose level in Phase 1; no upper BSA limits in Phase 2
- Participant and/or guardian must understand and be willing to sign informed consent
- Participant must have measurable or evaluable disease
- Participants receiving corticosteroids must be on stable or decreasing dose for at least 1 week prior to enrollment
- Performance score (Lansky <16 years or Karnofsky ≥16 years) must be 50 or higher with minimum life expectancy of 6 weeks
- Adequate bone marrow, organ, renal, and cardiac function as defined in the protocol
- Blood pressure must be controlled within specified limits for age and gender
- Participants of childbearing potential must agree to use contraception
- Participants must have confirmation of eligible tumor types per central pathology review
- Tumor must show evidence of MAPK pathway activation or participant must have known relevant germline mutation
- For Phase 1: tumor must be progressive or recurrent without prior MEK inhibitor exposure
- Prior chemotherapy and radiation must meet protocol timelines for last treatment
- No prior MEK inhibitor exposure for Phase 1 and Phase 2 Cohorts 1 and 2
- Cohort 1: Newly diagnosed or previously untreated except surgery; tumor must warrant treatment
- Cohort 2: Progressive or recurrent tumor without prior MEK inhibitor exposure
- Cohort 3A: Prior MEK inhibitor treatment ≥6 cycles without progression on therapy, progression off therapy
- Cohort 3B: Prior non-mirdametinib MEK inhibitor treatment with progression on therapy
- Participants must recover from prior treatment toxicities according to protocol timelines
You will not qualify if you...
- Tumor classified as high-grade (WHO III or IV), subependymal giant cell astrocytoma, ependymoma, histone H3 or BRAF V600 mutant, NTRK1/2/3, ALK, ROS1 fusion-positive, or IDH 1/2 mutant
- Currently receiving other anticancer or investigational agents (except ^11C-methionine) or recovering from related toxicity
- Known retinal diseases including central serous retinopathy, retinal vein occlusion, retinal detachment, or uncontrolled glaucoma
- Clinically significant medical disorders that could affect treatment tolerance or study participation
- Sexually active patients of reproductive potential not agreeing to effective contraception
- Unable to comply with protocol guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
T
Tabatha E. Doyle, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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