New brain cancer drug combo enters first human tests
NCT ID NCT07185880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called MT-125 given together with standard radiation for people newly diagnosed with a fast-growing brain tumor called glioblastoma. The main goals are to find a safe dose and understand side effects. About 36 adults aged 18 and older with a specific type of glioblastoma (IDH wild-type, MGMT-unmethylated) can join. This is the first time MT-125 is tested in humans, so its safety and effectiveness are not yet known.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years at the time of signing the informed consent form (ICF). 2. New Diagnosed with histologically or molecularly confirmed IDH wild type and MGMT unmethylated GBM. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2. 4. The following laboratory values obtained ≤15 days prior to registration: 1. Hemoglobin ≥9.0 g/dL 2. Absolute neutrophil count (ANC) ≥1500/mm3 3. Platelet count ≥100,000/mm3 4. Total bilirubin ≤1.5 x upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN (or ≤5 x ULN for participants with liver involvement) 6. 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 7. Serum eGFR ≥60 ml/min 5. 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) 6. Echocardiographic Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 55%. 7. 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 pregnancy test will be repeated. 8. Has provided written informed consent. 9. Ability to complete questionnaire(s) by themselves or with assistance. 10. Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study). 11. On a stable dose of steroids for at least 2 weeks prior to enrollment Exclusion Criteria: 1. 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: 1. Pregnant persons 2. Nursing persons 3. Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception. 2. 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 assessment of safety and toxicity of the prescribed regimens. 3. Receiving any other investigational agent. 4. 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 study or interfere with the interpretation of study data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Mayo Clinic Hospital
RECRUITINGPhoenix, Arizona, 85054, United States
Contact Email: •••••@•••••
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Mayo Clinic Hospital
RECRUITINGJacksonville, Florida, 32224, United States
Contact Email: •••••@•••••
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Mayo Clinic Hospital
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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