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New treatment option for Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Official title 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
ClinicalTrials.gov ID: NCT05765812
What this study is testing
What is Debio 0123?
Debio 0123 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma idh (isocitrate dehydrogenase) wildtype.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Screening for Phase 1 and Phase 2:
- Signed written informed consent approved before undertaking any study-specific procedures.
- Age ≥18 years of age.
- Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.
- Adequate bone marrow, hepatic, and renal function.
You likely can't join if
- 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...
- Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.
- Any anticancer treatment, monoclonal antibodies/biologics, investigational treatment, or RT with curative intent within 28 days prior to starting...
- Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ.
- Prior exposure to any WEE1 inhibitor.
- History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial...
See the full eligibility criteria
- Screening for Phase 1 and Phase 2:
- Signed written informed consent approved before undertaking any study-specific procedures.
- Age ≥18 years of age.
- Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.
- Adequate bone marrow, hepatic, and renal function.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Willing to practice highly effective methods of contraception.
- Life expectancy of at least 3 months in the best judgment of the Investigator.
- Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).
- 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.
- Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs. Additional specific 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...
- Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.
- KPS ≥60. Additional specific for Phase 1 Arm A:
- Participants must have one of the following histopathologically proven diagnoses (WHO 2021):
- GBM Isocitrate dehydrogenase (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 for Phase 1 Arm B and C:
- Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior...
- KPS ≥70. Additional specific 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
- 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
- Known contraindication to undergoing for Gd-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 any of the excipients found in the formulation for Debio 0123 or TMZ.
- Prior exposure to any WEE1 inhibitor.
- 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...
- Left ventricular ejection fraction (LVEF) below 55%. Additional specific exclusion criteria for Phase 1 Arm B and C:
- Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.
- Prior therapy that would result in an overlap of the radiation fields. 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- New York, New York, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Barcelona, Spain
- Donostia / San Sebastian, Spain
- Madrid, Spain
- Pamplona, Spain
- Valencia, Spain
- Zurich, Switzerland
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; New York, New York, United States; Dallas, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States; Salt Lake City, Utah, United States and 7 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.