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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515009-24-00

Enrollment

Registered

2026-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade malignant brain neoplasm

Brief summary

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.

Detailed description

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.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Outcome results