Testing the drug Debio 0123 with temozolomide in adults with glioblastoma
Official title: 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
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study is testing a drug called Debio 0123 added to usual glioblastoma: The fastest-growing type of glioma (grade 4). Treatment usually starts soon after diagnosis: surgery first, then radiation and chemotherapy. See the glossary treatment.
Read our full plain-language summary
What the trial team says
The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm. The primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development. The Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.
Key facts
- Registry number
- NCT05765812
- Stage of testing
- Phase 1/Phase 2
- Conditions studied
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III
Where it is running
This trial lists 16 sites.
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Illinois
- Northwestern Memorial Hospital (Chicago)
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New York
- New York University Langone Medical Center (New York)
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center (New York)
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Spain
- Hospital Universitario Vall d'Hebron (Barcelona)
- Hospital Universitario Donostia (Donostia / San Sebastian)
- Clinica Universidad de Navarra (CUN) (Madrid)
- South Texas Accelerated Research Therapeutics (START) (Madrid)
- Hospital Universitario 12 de Octubre (Madrid)
- Clinica Universidad de Navarra (CUN) (Pamplona)
- Hospital Clinico Universitario de Valencia (Valencia)
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Switzerland
- Universitaetsspital Zuerich (Zurich)
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Texas
- Baylor Scott & White Research Institute (Dallas)
- The University of Texas MD Anderson Cancer Center (Houston)
- South Texas Accelerated Research Therapeutics (START) (San Antonio)
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Utah
- Huntsman Cancer Institute (Salt Lake City)
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Washington
- Fred Hutchinson Cancer Research Center (Seattle)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.