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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
MinorEligibility criteria expanded, about 25 words
Secondary endpoints: details revised at 2 of 14 entries
Site details revised at 2 of 16 sites
Minor2 versionsRe-verified since Jul 23, 2026, no change to tracked fieldsv39-v40
MinorStudy sites: 17 to 16v38
Minor7 versionsRe-verified since Nov 28, 2025, no change to tracked fieldsv31-v37
MinorSite details revised at 2 of 17 sitesv30
Show 28 earlier versionsHide 28 earlier versions
MinorSite details revised at 2 of 17 sitesv29
Minor2 versionsRe-verified since Jul 29, 2025, no change to tracked fieldsv27-v28
MinorStudy sites: 16 to 17v26
MinorStudy sites: 15 to 16v25
Minor2 versionsRe-verified since Mar 31, 2025, no change to tracked fieldsv23-v24
MinorStudy sites: 14 to 15v22
MinorEnrollment target: 132 to 116
Study sites: 12 to 14
Eligibility criteria shortened, about 14 words
v21
Minor2 versionsRe-verified since Nov 27, 2024, no change to tracked fieldsv19-v20
MinorSite details revised at 1 of 12 sitesv18
MinorStudy sites: 11 to 12v17
MinorRe-verified, no change to tracked fieldsv16
MinorStudy sites: 10 to 11v15
NotablePrimary endpoints: 5 to 9v14Show 4 more changesShow less
Enrollment target: 120 to 132
Eligibility criteria expanded, about 32 words
Secondary endpoints: 10 to 14
Study arms: 3 to 5
MinorRe-verified, no change to tracked fieldsv13
NotableStart date: Mar 1, 2023 to May 15, 2023v12
NotablePrimary completion date: Jan 2025 to Sep 2028
Enrollment target: 89 to 120
Study completion date: Mar 2028 to Sep 2028
v11
Minor3 versionsRe-verified since Oct 27, 2023, no change to tracked fieldsv8-v10
MinorSite details revised at 1 of 10 sitesv7
MinorSite details revised at 1 of 10 sitesv6
MinorSite details revised at 1 of 10 sitesv5
MinorStudy sites: 6 to 10v4
MinorStudy sites: 3 to 6v3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 2 to 3
Start date changed from estimate of Mar 2023 to Mar 1, 2023
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.