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
Recruiting now · Phase 1/Phase 2
Conditions studied: Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III
In brief
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
- Study ID
- NCT05765812
- Run by
- Debiopharm International SA
- People needed
- 116
- Starts
- 2023-05-15
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
- New York University Langone Medical Center — New York, New York, United States (enrolling)
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Baylor Scott & White Research Institute — Dallas, Texas, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (enrolling)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
- Hospital Universitario Donostia — Donostia / San Sebastian, Spain (enrolling)
- Clinica Universidad de Navarra (CUN) — Madrid, Spain (enrolling)
- South Texas Accelerated Research Therapeutics (START) — Madrid, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Clinica Universidad de Navarra (CUN) — Pamplona, Spain (enrolling)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (enrolling)
- Universitaetsspital Zuerich — Zurich, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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