South Texas Accelerated Research Therapeutics | START Madrid - CIOCC
Status and phase
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About
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.
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Inclusion and exclusion criteria
Screening Inclusion Criteria for Phase 1 and Phase 2:
Additional specific inclusion criteria for Phase 1 and Phase 2:
• A maximum of 1 [for Phase 1 (Dose Expansion) and phase 2] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).
Note: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers [GLIADEL®]) for first recurrence is allowed.
Additional specific inclusion criteria for Phase 1 Arm A:
Additional specific inclusion criteria for Phase 1 Arm B and C:
Additional specific inclusion criteria for Phase 1 dose expansion and Phase 2:
• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021
Additional specific exclusion criteria for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3
Additional specific exclusion criteria for Phase 1 and Phase 2
Additional specific exclusion criteria for Phase 1 Arm B and C:
Additional specific exclusion criteria for Phase 1 dose expansion and Phase 2
• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.
[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.]
Primary purpose
Allocation
Interventional model
Masking
132 participants in 5 patient groups
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Central trial contact
Debiopharm International S.A
Data sourced from clinicaltrials.gov
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