A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

Astrocytoma, Grade III Clinical Trial

Official title:
A Phase 1/2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

Status Recruiting

Clinical Trial Summary

The primary purpose of Phase 1 (dose escalation) of this study is to identify the recommended Phase 2 dose (RP2D) of Debio 0123 in combination with temozolomide (TMZ) (Arm A) and in combination with TMZ and radiotherapy (RT) (Arm B) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). The primary purpose of Phase 2 of this study is to assess the efficacy of Debio 0123 at the RP2D in combination with TMZ, compared to standard of care (SOC) in adult participants with GBM.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Astrocytoma
Astrocytoma, Grade III
Glioblastoma
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Clinical Trial Details

NCT number	NCT05765812
Study type	Interventional
Source	Debiopharm International SA
Contact	Debiopharm International S.A
Phone	+41 21 321 01 11
Email	clinicaltrials@debiopharm.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	May 15, 2023
Completion date	September 2028

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02655601` - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001	Phase 2
Active, not recruiting	`NCT03450850` - Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma	N/A
Completed	`NCT02644291` - Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors	Phase 1
Terminated	`NCT03906448` - FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma	Phase 2
Completed	`NCT04757662` - Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma	Phase 1
Not yet recruiting	`NCT06161974` - Study of Olutasidenib and Temozolomide in HGG	Phase 2
Completed	`NCT03224104` - Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma	Phase 1
Terminated	`NCT02722512` - Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine	Phase 1
Recruiting	`NCT06118723` - The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
Withdrawn	`NCT03956706` - Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas	N/A
Recruiting	`NCT03596086` - HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM	Phase 1/Phase 2
Recruiting	`NCT04304300` - Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes
Completed	`NCT03072134` - Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma	Phase 1