Clinical Trials Logo
  1. Home
  2. Newly Diagnosed Glioblastoma
  3. NCT04967690

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03899857 - Pembrolizumab for Newly Diagnosed Glioblastoma Phase 2
Active, not recruiting NCT05163080 - SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) Phase 2
Recruiting NCT04474353 - Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma Phase 1
Recruiting NCT05235737 - The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab Phase 4
Recruiting NCT04840069 - Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma Phase 2
Active, not recruiting NCT03400917 - Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma Phase 2
Completed NCT03619239 - Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma Phase 1
Completed NCT03345095 - A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma Phase 3
Recruiting NCT04478279 - A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05864534 - Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma Phase 2
Active, not recruiting NCT04600817 - A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT) Phase 2
Active, not recruiting NCT03782415 - Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma Phase 1/Phase 2
Recruiting NCT04477200 - Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma Phase 1
Withdrawn NCT04065087 - Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma Phase 1/Phase 2
Recruiting NCT05380349 - Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma Early Phase 1