Condition: Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype · Astrocytoma, Grade III · Sponsor: Debiopharm International SA
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.
This description comes directly from the study's public registry record.
Debiopharm International S.A · +41 21 321 01 11 · clinicaltrials@debiopharm.com
Always discuss trial participation with your own doctor first.
| Northwestern Memorial Hospital | Chicago, Illinois, United States | Recruiting |
| New York University Langone Medical Center | New York, New York, United States | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York, New York, United States | Recruiting |
| Baylor Scott & White Research Institute | Dallas, Texas, United States | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| South Texas Accelerated Research Therapeutics (START) | San Antonio, Texas, United States | Recruiting |
| Huntsman Cancer Institute | Salt Lake City, Utah, United States | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle, Washington, United States | Recruiting |
| Hospital Universitario Vall d'Hebron | Barcelona, Spain | Recruiting |
| Hospital Universitario Donostia | Donostia / San Sebastian, Spain | Recruiting |
| Clinica Universidad de Navarra (CUN) | Madrid, Spain | Recruiting |
| South Texas Accelerated Research Therapeutics (START) | Madrid, Spain | Recruiting |
+ 4 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05765812