A Phase 1/2 Study of Safety and Tolerability of MT-125 With Chemoradiation in Patients With Newly Diagnosed MGMT Methylated Glioblastoma
Condition(s) studied
Investigational drug(s) / intervention(s)
MT-125: This is an investigational new drug under IND 170975.
Study summary
This is a Phase 1, single-arm MT-125 dose escalation study followed by a Phase 2, randomized parallel design dose expansion phase, to determine the safety and tolerability of MT-125 administered 5 consecutive days a week with 2 days off for the 6 weeks of outpatient treatment of Radiotherapy (RT) plus TMZ. Participants with newly diagnosed histologically or molecularly confirmed IDH wild type and MGMT methylated GBM will be eligible to enroll. The dose-limiting toxicity (DLT) observation window will be 6 weeks, starting with the first dose of MT-125 administration and chemoradiation. A Bayesian Optimal Interval (BOIN) adaptive trial design will be used to efficiently evaluate up to four dose levels. Secondary endpoints for this Phase 1/2 study will include determination of the MTD, the systemic PK of MT-125, and the RP2D of MT-125. Once the MTD is defined, additional participants will be enrolled as part of an expansion cohort, with a randomized parallel design, which will include up to 2 dose levels which are expected to be MTD and one dose below the MTD. Up to 36 participants will be enrolled in the study (up to 24 participants in the dose escalation phase and up to a total of 12 participants maximum per dose level for the two expansion cohorts).
Eligibility
Primary outcome measure(s)
- Dose Limiting Toxicity Measurement — 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 AEs — 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.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | |
| Mayo Clinic Hospital | Jacksonville | Florida | |
| Mayo Clinic Hospital | Rochester | Minnesota |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07604285 on ClinicalTrials.gov ↗ ← All trials in the USA