SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

Eligibility Criteria

• * Participants with histologically confirmed or suspected low-grade glioma, including neuronal and mixed neuronal-glial tumors
• * Participant must have adequate tumor tissue from primary and/or relapsed tumor for central pathology review
• * For Phase 1: Projected to be ≥ 2 years and \< 25 years at the time of study enrollment
• * Participant's body surface area (BSA) at time of study enrollment must fall within the range outlined in the protocol for the specific dose level under evaluation:
• * Phase 1: Dose Finding/Dose-escalation
• * For Phase 1 participant's BSA must fall within the range specified in the protocol for the specific dose level under evaluation.
• * Phase 2: All Cohorts:
• * For Phase 2 of the study the upper BSA restrictions will be removed.
• * Participant and/or guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
• * Participants with known current retinal pathology that is consistent with or a precursor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration
• * Participants with a known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of mirdametinib (e.g., gastric bypass, lap band, or other gastric procedures)
• * Participant with a known history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
• * Participants with a clinically significant history of chronic interstitial lung disease (such as bronchopulmonary dysplasia, chronic bronchiolitis, obliterative bronchiolitis, chronic aspiration pneumonia, surfactant protein disorder, or other serious chronic pulmonary condition). Participants with a history of asthma, reactive airways disease, or viral pneumonitis are not to be excluded if disease has resolved or is well-controlled.