OncoMatch/Clinical Trials/NCT05804227
Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas
Is NCT05804227 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies multiple treatments including Ulixertinib and Ulixertinib for gliomas.
Treatment: Ulixertinib · Ulixertinib — To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
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 →Frequently asked questions
Is NCT05804227 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior VEGF inhibitor, chemotherapy, targeted small molecule therapy disqualifies patients from enrollment.
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 qualify