Phase 1/2 Study of MT-125 for Glioblastoma
This study is testing a new drug called MT-125 for people diagnosed with glioblastoma (a type of brain tumor). Researchers want to find the safest and most effective dose of MT-125 when given along with standard radiation treatment. MT-125 is designed to target cancer cells and help radiation therapy work better. You might be able to join if you are at least 18 years old, have newly diagnosed glioblastoma, and meet certain health requirements. The study will look at any side effects and how well people tolerate MT-125 during the first six weeks of treatment. Up to 36 people are expected to participate.
- Study design
- This is an interventional study planning to enroll up to 36 participants. It is a Phase 1/2 study, meaning it will first look at safety and then at effectiveness.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety and tolerability of MT-125 will be measured during the first 6 weeks of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- Dose Limiting Toxicity MeasurementFrom Day 1 through 6 weeks of treatment
The dose escalation portion of this study will follow a BOIN design with cohorts containing a min of 3 DLT evaluable participants. If the observed DLT rate at the current dose is ≤0.236, then the decision will be to escalate the dose to the next higher dose level; if the observed DLT rate at the current dose is \>0.359, then the decision will be to deescalate the dose to the next lower dose level; otherwise, the decision will be to stay at the current dose level.
- Incidence and Severity of AEsFrom Day 1 through 6 weeks of treatment
Incidence and Severity, attribution, grade and type of AE will be assessed based on the NCI CTCAE v5.