A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2025

Conditions
Newly Diagnosed Glioblastoma
Interventions
DRUG

SI-053

SI-053 will be used as an add-on to SoC for newly diagnosed GBM.In conjunction with surgical resection, SI-053 will be applied intracranially (i.c.) into the cavity that is formed after tumor resection. Post-operative chemoradiotherapy (including concomitant and adjuvant TMZ or following the CeTeG protocol) will be initiated at least 21 and no later than 35 days after SI-053 administration.

Sponsors
All Listed Sponsors
lead

Double Bond Pharmaceutical AB

INDUSTRY