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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 — TARGLIO  

Newly Diagnosed Glioblastoma Clinical Trial

Official title:
An Open-label Dose Escalation Study to Estimate MTD, Identify DLTs and Study Pharmacokinetics Following a Single Dose of Intracranially Administered Temozolomide-based SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed Glioblastoma

Clinical Trial Summary

SI-053 is a novel powder formulation containing temozolomide (TMZ), an alkylating chemotherapy agent, in an excipient which forms a viscous gel upon reconstitution in water. SI-053 will be used as an add-on to SoC for newly diagnosed GBM. SoC consists of maximal safe resection followed by radiation therapy (RT) with concomitant TMZ and adjuvant chemotherapy with TMZ. For MGMT promoter methylated GBM, lomustine and TMZ may be administered plus radiation therapy

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04967690
Study type Interventional
Source Double Bond Pharmaceutical AB
Contact Lili Li, PhD
Phone 0046 (0)737206568
Email lili@doublebp.com
Status Not yet recruiting
Phase Phase 1
Start date January 2024
Completion date December 2025
View Details
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