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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
EU CTIS ID: 2022-502156-31-00
What this study is testing
Phase 1 Arms A and B/C: To characterize the safety and tolerability of Debio 0123 combined with TMZ (Arm A) and with TMZ and RT (Arm B and C) and to select the Debio 0123 doses for further investigation. Phase 1 Dose expansion: To identify the RD of Debio 0123 combined with TMZ for further development. Phase 2: To assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Phase 1 and Phase 2 Signed written informed consent approved before undertaking any study-specific procedures.
- Phase 1 and Phase 2 Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Additional specific criteria for Phase 1 Arm A Participants must have one of the following histopathologically proven diagnoses (WHO 2021) • GBM IDH-wildtype, Grade 4, which may include secondary GBMs (i.e., those that progress from low-grade gliomas) • Astrocytoma, IDH-mutant, Grade 3
- Additional specific criteria for Phase 1 Arm B/C: Participants must have a new, histopathologically proven diagnosis (WHO 2021) of GBM, IDH-wildtype, Grade 4, which may include secondary GBMs (i.e., those that progress from low-grade gliomas).
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 A maximum of 1 (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)
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.
You likely can't join if
- Phase 1 and Phase 2 History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
- Phase 1 and Phase 2 Prior exposure to any WEE1 inhibitor
- Additional specific 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.
- Specific criteria for Phase 1 Arm A Prior treatment with bevacizumab or with other vascular endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors.
- Specific criteria for Phase 1 Arm A Prior TMZ-related hematological event leading to discontinuation of TMZ during the concurrent chemoradiotherapy.
- Additional specific criteria for Phase 1 Arm B/C Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.
See the full eligibility criteria
Who can join
- Phase 1 and Phase 2 Signed written informed consent approved before undertaking any study-specific procedures.
- Phase 1 and Phase 2 Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Additional specific criteria for Phase 1 Arm A Participants must have one of the following histopathologically proven diagnoses (WHO 2021) • GBM IDH-wildtype, Grade 4, which may include secondary GBMs (i.e., those that progress from low-grade gliomas) • Astrocytoma, IDH-mutant, Grade 3
- Additional specific criteria for Phase 1 Arm B/C: Participants must have a new, histopathologically proven diagnosis (WHO 2021) of GBM, IDH-wildtype, Grade 4, which may include secondary GBMs (i.e., those that progress from low-grade gliomas).
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 A maximum of 1 (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)
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 C) KPS ≥60.
- Additional specific criteria for Phase 1 Arm B/C B) KPS ≥70.
- Additional specific criteria for Phase 1 dose expansion and Phase 2 Participants must have a histopathologically proven diagnosis (WHO 2021) of GBM, IDH-wildtype, Grade 4.
- Phase 1 and Phase 2 Age ≥18 years of age.
- Phase 1 and Phase 2 Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.
- Phase 1 and Phase 2 Adequate bone marrow, hepatic, and renal function
- Phase 1 and Phase 2 Life expectancy of at least 3 months in the best judgment of the Investigator
- Phase 1 and Phase 2 Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.
- Phase 1 and Phase 2 Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.
- Phase 1 and Phase 2 Measurable or non-measurable disease per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).
- Phase 1 and Phase 2 Willing to practice highly effective methods of contraception.
What rules you out
- Phase 1 and Phase 2 History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
- Phase 1 and Phase 2 Prior exposure to any WEE1 inhibitor
- Additional specific 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.
- Specific criteria for Phase 1 Arm A Prior treatment with bevacizumab or with other vascular endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors.
- Specific criteria for Phase 1 Arm A Prior TMZ-related hematological event leading to discontinuation of TMZ during the concurrent chemoradiotherapy.
- Additional specific criteria for Phase 1 Arm B/C Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.
- Specific criteria for Phase 1 Arm B/C Prior therapy that would result in an overlap of the radiation fields.
- Additional specific 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. Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1systemic line
- Phase 1 and Phase 2 Known contraindication for Gd-based, contrast-enhanced MRI.
- Phase 1 and Phase 2 Left ventricular ejection fraction (LVEF) below 55%.
- Phase 1 and Phase 2 Chemotherapy, monoclonal antibodies/biologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.
- Phase 1 and Phase 2 Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.