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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony diagnozą glejaka mózgu (glioblastoma)
- •Wcześniejsze leczenie chemioterapią z promieniowaniem (TMZ z radioterapią)
- •Zadowalająca funkcja wątroby, nerek i szpiku kostnego
- •Oczekiwana długość życia co najmniej 3 miesiące
- •Zdolność do uczestniczenia w regularnych wizytach i badaniach
- •Kontrolowane napady padaczki (jeśli dotyczy)
- •Stabilna dawka kortykosteroidów (jeśli stosowane)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (16)
Northwestern Memorial Hospital
Chicago, United States
New York University Langone Medical Center
New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, United States
Baylor Scott & White Research Institute
Dallas, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, United States
Huntsman Cancer Institute
Salt Lake City, United States
Fred Hutchinson Cancer Research Center
Seattle, United States
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Clinica Universidad de Navarra (CUN)
Madrid, Spain
South Texas Accelerated Research Therapeutics (START)
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Clinica Universidad de Navarra (CUN)
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Universitaetsspital Zuerich
Zurich, Switzerland
Trial contact
Debiopharm International S.A
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.
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