INTRATUMORAL DNX-2401 ADMINISTRATION FOR RECURRENT AND REFRACTORY HIGH GRADE BRAIN TUMORS IN PEDIATRIC AND YOUNG ADULT PATIENTS

Condition studied

High grade malignant brain neoplasm

Eligibility

Primary endpoint

Overall response rate (ORR), defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD for at least 12 weeks) as best response according to RAPNO criteria.

Endpoint detail

Number of AEs and SAEs per NCI-CTCAE criteria in first 12 weeks after DNX-2401 administration., Time to response., Duration of response., PFS, OS: 6- and 12- month PFS and OS rates., LPS/KPS and QoL (PedsQL™ Generic Score Scale) parameters compared to baseline.