MT-125 with Chemoradiation for Newly Diagnosed Glioblastoma
This study is testing a new drug called MT-125 along with standard chemoradiation (chemotherapy and radiation therapy) for people with newly diagnosed glioblastoma (a type of brain cancer). You might be able to join if you are 18 or older and have glioblastoma that has specific genetic markers (IDH wildtype and MGMT methylated). Researchers want to see how safe MT-125 is and what side effects it might cause when given with chemoradiation. They will also look at how well people tolerate the treatment. The study aims to enroll 36 participants. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2 study, starting with a single-arm dose escalation phase followed by a randomized parallel design dose expansion phase. It plans to enroll 36 participants.
- What's involved
- MT-125 will be administered 5 consecutive days a week with 2 days off for 6 weeks of outpatient treatment with radiotherapy and TMZ. Dose-limiting toxicity and side effects will be measured from Day 1 through 6 weeks of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Side effects and dose-limiting toxicity will be measured for 6 weeks after starting 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 Safety and Tolerability of MT-125 With Chemoradiation in Patients With Newly Diagnosed MGMT Methylated Glioblastoma
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 MeasurementDay 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 AEsDay 1 through 6 weeks of treatment
Incidence and Severity, attribution, grade and type of AE will be assessed based on the NCI CTCAE v5.