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New treatment option for Glioblastoma (GBM)
Official title BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors
ClinicalTrials.gov ID: NCT07485049
What this study is testing
What is BGB-58067?
BGB-58067 is an investigational medicine, being studied as a potential treatment for glioblastoma (gbm).
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
- This is an open-label, multi-center, Phase 0/2 trial designed to enroll up to 78 total participants with suspected newly diagnosed glioblastoma (nGBM) who are scheduled for surgical resection to accrue at least 14 participants in Arm A and 10 participants in Arm B. The trial will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of BGB-58067.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
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
- 1\. Suspected newly diagnosed glioblastoma according to 2021 WHO criteria who have not received any tumor directed intervention other than biopsy.
- 2\. Has measurable disease (preoperatively), defined as at least one contrast-enhancing lesion with two perpendicular measurements of at least 1 cm.
- 3\. Age ≥ 18 at time of consent.
- 4\. Has a performance status of ≤ 2 on the ECOG scale.
- 5\. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
You likely can't join if
- 1\. Unable to undergo MRI of the brain with intravenous (IV) contrast.
- 2\. Has a known active systemic bacterial infection (on IV antibiotics or has fever \> 38.5°C at time of initiating study treatment) or fungal...
- 3\. Has cardiovascular abnormalities including:
- LVEF \< 50%
- History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \> 480 msec, except for right bundle...
- Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the...
See the full eligibility criteria
Who can join
- 1\. Suspected newly diagnosed glioblastoma according to 2021 WHO criteria who have not received any tumor directed intervention other than biopsy.
- 2\. Has measurable disease (preoperatively), defined as at least one contrast-enhancing lesion with two perpendicular measurements of at least 1 cm.
- 3\. Age ≥ 18 at time of consent.
- 4\. Has a performance status of ≤ 2 on the ECOG scale.
- 5\. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
- Adequate Bone Marrow Function Absolute neutrophil count ≥ 1500/μL (≥ 1.5 x 109/L) Platelets (at time of surgery) ≥ 100,000/μL (≥ 100 x 109/L) Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (Criteria must be met without...
- Adequate Hepatic Function Total Bilirubin ≤ 1.5x ULN (Participants with Gilbert's syndrome with a total bilirubin ≤ 3x ULN and direct bilirubin ≤ 1.5x ULN will be permitted.) AST (SGOT) ≤ 2.5x institutional ULN...
- Adequate Renal Function eGFR ≥ 60 mL/min/1.73 m2 (Calculated as individualized eGFR using the CKD-EPI formula [2021]) If measured or calculated GFR (e.g., creatinine clearance; mGFR) is required or used: ≥ 60 mL/min
- Adequate Metabolic Function Albumin ≥ 2.8 g/dL
- Adequate Coagulation INR or PT and aPTT ≤ 1.5x ULN
- 6\. For females of childbearing potential:
- Must have a confirmed negative serum pregnancy test (β-hCG) before starting study treatment (within 24 hours of first dose of study treatment); in rare cases where hCG is suspected to be elevated in the absence of...
- Must use a highly effective method of contraception (with a failure rate of \<1% per year and low user dependency) for at least 28 days prior to treatment, and agree to use such a method during study participation and...
- Agrees not to breastfeed starting at screening, during study participation, and for 6 months after final study drug administration.
- Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction starting at screening, during study participation, and for 6 months after final study drug administration.
- 7\. For females of non-childbearing potential, is no longer of childbearing potential due to surgical, chemical, or natural menopause.
- 8\. For males:
- Agrees not to donate sperm starting at screening, during study participation, and for 3 months after final study drug administration.
- Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agrees to remain abstinent starting at screening, during study participation, and for 3...
- 9\. Agrees to adhere to protocol defined Lifestyle Considerations throughout study duration.
- 10\. Able and willing to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
- 11\. Understands the informed consent document and has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written...
What rules you out
- 1\. Unable to undergo MRI of the brain with intravenous (IV) contrast.
- 2\. Has a known active systemic bacterial infection (on IV antibiotics or has fever \> 38.5°C at time of initiating study treatment) or fungal infection, or has a detectable viral infection (such as known human...
- 3\. Has cardiovascular abnormalities including:
- LVEF \< 50%
- History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \> 480 msec, except for right bundle branch block.
- Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following: cardiac angioplasty or stenting, unstable angina pectoris...
- 4\. Has symptomatic or radiographic leptomeningeal disease.
- 5\. Has other known concurrent severe psychiatric and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risks, contraindicate participation in the clinical study, or...
- 6\. Has received prior treatment with another investigational drug or other intervention within 5 half lives of the investigational product, whichever is longer.
- 7\. Has received prior treatment with another PRMT5 inhibitor.
- 8\. Has known allergic reactions to components of BGB-58067.
- 9\. Patients who require ongoing treatment with a strong CYP3A or CYP2C8 inhibitor or inducer, ≤ 5 half-lives or ≤ 14 days, whichever is shorter or known. Consider using alternative medications, per Investigator...
- 10\. Has received a live/attenuated vaccine within 30 days of anticipated first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted.
- 11\. Is pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Phoenix, Arizona, 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 ClinicalTrials.gov; the study team decides eligibility.