At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Adequate bone marrow, hepatic, and renal function
- ✓Life expectancy of at least 3 months
- ✓Measurable or non-measurable disease per RANO criteria on gadolinium-based contrast-enhanced brain MRI
- ✕Known contraindication to gadolinium-based contrast-enhanced MRI
- ✕Any anticancer treatment, monoclonal antibodies/biologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment
- ✕Hypersensitivity to Debio 0123, TMZ, dacarbazine, or excipients
- ✕Prior exposure to any WEE1 inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Open-label 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
In Brief
A Phase 2 clinical trial evaluating Debio 0123, Temozolomide, and 1 other intervention for Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype and Astrocytoma, Grade III. Currently recruiting, targeting 116 participants across 16 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered as capsules.
Administered as capsules.
Administered in accordance with the local clinical practice and applicable Radiation Therapy Oncology Group (RTOG) or the European Organization for Research and Treatment of Cancer (EORTC) guidelines.