OncoMatch/Clinical Trials/NCT05765812
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
Is NCT05765812 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Debio 0123 and Temozolomide for glioblastoma idh (isocitrate dehydrogenase) wildtype.
Treatment: Debio 0123 · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Required: IDH1 wild-type
Required: IDH2 mutation
Required: IDH2 wild-type
Prior therapy
Must have received: temozolomide-based chemoradiotherapy (temozolomide, radiotherapy) — first-line
first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT)
Cannot have received: WEE1 inhibitor
Prior exposure to any WEE1 inhibitor
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Cardiac function
Left ventricular ejection fraction (LVEF) below 55% [excluded]
Adequate bone marrow, hepatic, and renal function. Left ventricular ejection fraction (LVEF) below 55% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern Memorial Hospital · Chicago, Illinois
- New York University Langone Medical Center · New York, New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center · New York, New York
- Baylor Scott & White Research Institute · Dallas, Texas
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05765812 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior WEE1 inhibitor disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 mutation is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages