OncoMatch/Clinical Trials/NCT05773326
Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG
Is NCT05773326 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Temsirolimus for high grade glioma.
Treatment: Temsirolimus — This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion. Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MTOR overexpression (mTOR+)
Tissue must demonstrate mTOR+
Required: PTEN loss
PTEN loss
Required: PIK3C2B amplification
PIK3C2B amplification on aCGH
Required: AKT3 amplification
AKT3 amplification on aCGH
Required: PIK3CA mutation
PIK3CA mutation using next-generation sequencing analysis
Required: PIK3R1 mutation
PIK3R1 mutation using next-generation sequencing analysis
Required: MTOR mutation
mTOR mutation using next-generation sequencing analysis
Required: PTEN mutation
PTEN mutation using next-generation sequencing analysis
Required: RPS6 overexpression (pS6 positivity ≥30%) (≥30%)
pS6 positivity on immunohistochemistry (≥30% for pS6)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: stupp regimen
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Joseph's Hospital and Medical Center · Phoenix, Arizona
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