MT-125 for Glioblastoma
(NOVA-GBM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Are You a Good Fit for This Trial?
This trial is for adults (18+) with newly diagnosed glioblastoma that is IDH wildtype and MGMT methylated. Participants must be in reasonably good physical condition, have adequate blood counts, liver and kidney function, and stable clotting tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MT-125 with chemoradiation for 6 weeks, administered 5 consecutive days a week with 2 days off
Dose Escalation
Evaluation of up to four dose levels using a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD)
Randomized Expansion
Participants are enrolled into a randomized, parallel dose expansion cohort to receive either MTD or one dose lower than MTD
Follow-up
Participants are monitored for safety and effectiveness after treatment, including overall response rate (ORR), progression-free survival (PFS6), and overall survival (OS)
What Are the Treatments Tested in This Trial?
Interventions
- MT-125
Trial Overview
The study is testing different doses of a new drug called MT-125 given along with standard chemoradiation (radiotherapy plus temozolomide) to see if it’s safe and tolerable. The trial has two phases: first finding the best dose, then comparing selected doses.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Participants will be randomized to receive either MTD or one dose lower than MTD for 5 days, then off 2 days for a total of 6 weeks in combination with RT plus TMZ
Up to 6 participants will receive 83.5 mg of MT-125 for 5 days then off for 2 days for a total of 6 weeks in combination of RT plus TMZ
Up to 6 participants will receive 50 mg of MT-125 for 5 days then off for 2 days for a total of 6 weeks in combination of RT plus TMZ
Up to 6 participants will receive 25 mg of MT-125 for 5 days then off for 2 days for a total of 6 weeks in combination of RT plus TMZ
Up to 6 participants will receive 100 mg of MT-125 for 5 days then off for 2 days for a total of 6 weeks in combination of RT plus TMZ
Find a Clinic Near You
Who Is Running the Clinical Trial?
Myosin Therapeutics Inc.
Lead Sponsor
Mayo Clinic
Collaborator
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