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OncoMatch/Clinical Trials/NCT05804227

Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas

Is NCT05804227 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Ulixertinib and Ulixertinib for gliomas.

Early Phase 1RecruitingM.D. Anderson Cancer CenterNCT05804227Data as of May 2026

Treatment: Ulixertinib · UlixertinibTo learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors

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Extracted eligibility criteria

Biomarker criteria

Allowed: BRAF mutation

mutations in BRAF

Allowed: FGFR1 mutation

mutations in FGFR

Allowed: PTPN11 mutation

mutations in PTPN11

Allowed: NF1 mutation

somatic NF-1

Allowed: NF1 syndrome-associated gliomas

NF-1 syndrome-associated gliomas

Allowed: CIC mutation

CIC mutated

Allowed: MAPK1 activation

mutation or activation of the RAS/RAF/MEK/ERK pathway

Prior therapy

Must have received: radiation therapy — low grade glioma (grade 1, 2), oligodendroglioma (grade 2, 3), high grade glioma (grades 3 and 4 excluding oligodendroglioma)

Low grade gliomas patients (grade 1, 2) and oligodendroglioma (grade 2, 3) must have had prior radiation OR chemotherapy for the treatment of glioma. High grade glioma patients (grades 3 and 4 excluding oligodendroglioma) must have had prior radiation.

Must have received: chemotherapy — low grade glioma (grade 1, 2), oligodendroglioma (grade 2, 3)

Low grade gliomas patients (grade 1, 2) and oligodendroglioma (grade 2, 3) must have had prior radiation OR chemotherapy for the treatment of glioma.

Cannot have received: VEGF inhibitor (bevacizumab)

Exception: treatment with bevacizumab less than 3 months prior to enrollment

Treatment with bevacizumab less than 3 months prior to enrollment.

Cannot have received: chemotherapy

Exception: prior chemotherapy or targeted small molecule therapy within 3 weeks prior to study Day 1

Patient has had prior chemotherapy or targeted small molecule therapy, within 3 weeks prior to study Day 1

Cannot have received: targeted small molecule therapy

Exception: within 3 weeks prior to study Day 1

Patient has had prior chemotherapy or targeted small molecule therapy, within 3 weeks prior to study Day 1

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1,500 /mcL; Platelets ≥ 100,000 /mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L

Kidney function

Serum creatinine ≤1.5 X ULN OR ≥ 50 mL/min for patient with creatinine levels > 1.5 X institutional ULN

Liver function

Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 3.0 X ULN

Cardiac function

LVEF ≥ 50%

Demonstrate adequate organ function as defined in the Table below. All screening labs should be performed within 14 days (+3 working days) of treatment initiation.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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