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Tests treatment safety and results for Glioblastoma (GBM)
Official title A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients
ClinicalTrials.gov ID: NCT07185880
What this study is testing
What is MT-125?
MT-125 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
- The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment. Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Age ≥18 years at the time of signing the informed consent form (ICF).
- New Diagnosed with histologically or molecularly confirmed IDH wild type and MGMT unmethylated GBM.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
- The following laboratory values obtained ≤15 days prior to registration:
- Hemoglobin ≥9.0 g/dL
You likely can't join if
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the...
- Pregnant persons
- Nursing persons
- Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate...
- Receiving any other investigational agent.
See the full eligibility criteria
- Age ≥18 years at the time of signing the informed consent form (ICF).
- New Diagnosed with histologically or molecularly confirmed IDH wild type and MGMT unmethylated GBM.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
- The following laboratory values obtained ≤15 days prior to registration:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelet count ≥100,000/mm3
- Total bilirubin ≤1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN (or ≤5 x ULN for participants with liver involvement)
- Prothrombin time (PT)/ International normalized ratio (INR)/ Activated partial thromboplastin time (aPTT) ≤1.5 x ULN OR if participant is receiving anticoagulant therapy and INR or aPTT is within target range of therapy
- Serum eGFR ≥60 ml/min
- QTc 470 ms on triplicate 12 lead ECG ≤29 days prior to registration. NOTE: QTc intervals will be corrected using Fridericia's formula (Fridericia 1920)
- Echocardiographic Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 55%.
- Negative serum pregnancy test done ≤7 days prior to first dose of MT-125 administration, for persons of childbearing potential only. a. If \>7 days between last test and first dose of study treatment, the serum...
- Has provided written informed consent.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- On a stable dose of steroids for at least 2 weeks prior to enrollment
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper...
- Receiving any other investigational agent.
- Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, 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, 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; Jacksonville, Florida, United States; Rochester, Minnesota, 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.