ALERT-1NCT07902037
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Evaluation of the safety and tolerability of SRN-101 in adult participants with recurrent high-grade glioma.
Timeframe: From administration of SRN-101 through 12 months after treatment
Determination of the RP2D of SRN-101
Timeframe: Through determination of the RP2D following completion of dose escalation, approximately 18 months
Secondary (4)
Tumor response by Response Assessment in Neuro-Oncology (RANO) 2.0
Progression-free survival
Clinical benefit rate
Overall survival
Arms and interventions
SRN-101 treatmentExperimental
Each participant receives a single intratumoral infusion of SRN-101 using MRI-guided CED. In Part 1, successive cohorts receive different dose levels. In Part 2, participants receive the RP2D selected in Part 1.
Genetic: SRN-101