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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
NCT05765812 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Temozolomide
- RADIATION Radiotherapy
- DRUG Debio 0123
Study Locations (17)
Other
- 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 Universitario Donostia — San Sebastián
- Hospital Clinico Universitario de Valencia — Valencia
- Universitaetsspital Zuerich — Zurich
Texas
- Baylor Scott & White Research Institute — Dallas
- The University of Texas MD Anderson Cancer Center — Houston
- South Texas Accelerated Research Therapeutics (START) — San Antonio
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
Illinois
- Northwestern Memorial Hospital — Chicago
Utah
- Huntsman Cancer Institute — Salt Lake City
Washington
- Fred Hutchinson Cancer Research Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05765812
The ClinicalTrials.gov registry entry for NCT05765812 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Astrocytoma, Grade III appearing as the primary indexed condition, and to 3 interventions — of which Temozolomide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05765812 reports 17 study locations spanning 6 distinct geographic areas — top geographies include Other, Texas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05765812 about?
NCT05765812 is a clinical study titled "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". 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 adul...
What is the current status of trial NCT05765812?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2023-05-15. Estimated completion is 2028-09.
What conditions does trial NCT05765812 study?
This clinical trial studies the following conditions: Astrocytoma, Grade III, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05765812?
The interventions under investigation include: Temozolomide (DRUG), Radiotherapy (RADIATION), Debio 0123 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05765812?
This trial is sponsored by Debiopharm International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05765812 being conducted?
This trial has 17 study locations across Illinois, New York, Texas, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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