MT-125 for Glioblastoma
(NOVA-GBM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, MT-125, for glioblastoma, a type of brain cancer. Participants will receive MT-125 alongside standard treatments to assess its safety and effectiveness. The trial will explore different doses to determine the optimal one. Individuals recently diagnosed with a specific type of glioblastoma and stable on their medication might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how MT-125 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be on a stable dose of steroids for at least 2 weeks before enrolling. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that MT-125 is likely to be safe for humans?
Research has shown that MT-125 is generally well-tolerated in early studies, with a strong safety record indicating few serious side effects in initial tests. MT-125 is designed to effectively reach the brain, which is crucial for treating brain conditions like glioblastoma.
Other studies have focused on determining the optimal dose that works without causing excessive side effects. So far, results are promising, suggesting that MT-125 can be safely administered to patients with careful monitoring. However, further research is necessary to fully understand its safety in humans.12345Why are researchers excited about this trial's treatment?
Researchers are excited about MT-125 for treating glioblastoma because it offers a potentially new way to enhance the effects of radiation therapy (RT) and temozolomide (TMZ), the current standard treatments. Unlike traditional options, MT-125 works by possibly targeting specific cancer cell pathways that make tumor cells more vulnerable to RT and TMZ. This could lead to better outcomes for patients by making cancer cells easier to destroy and potentially improving survival rates. Additionally, the flexible dosing of MT-125, tested at various levels, might help personalize treatment plans to maximize effectiveness while minimizing side effects.
What evidence suggests that MT-125 might be an effective treatment for glioblastoma?
Research has shown that MT-125 could be promising for treating glioblastoma, a type of brain cancer. Studies have found that MT-125 can stop glioblastoma cells from spreading and help animals live longer. This treatment effectively reaches the brain and is well-tolerated in these studies. The FDA granted MT-125 "fast track" status, indicating its potential as an important new treatment for this aggressive cancer. Overall, early evidence suggests that MT-125 might help extend the lives of people with glioblastoma. Participants in this trial will receive different dosages of MT-125 to evaluate its effectiveness and safety.13567
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
Citations
MT-125 inhibits non-muscle myosin IIA and IIB and ...
MT-125 has high brain penetrance and an excellent safety profile, blocks GBM invasion and cytokinesis, and prolongs survival in murine GBM ...
A Phase 1/2 Study of the Safety and Tolerability of MT-125 ...
MT-125 inhibits non-muscle myosin IIA and IIB and prolongs survival in glioblastoma. Cell. 2025 Aug 21;188(17):4622-4639.e19. doi: 10.1016/j.cell.2025.05 ...
MT-125: A glimpse of hope for glioblastoma patients
MT-125 with its remarkable brain retention and in vivo tolerance impedes GBM invasion and extends the lifespan of murine GBM models through ...
FDA Awards Fast Track Designation to MT-125 for ...
MT-125 has shown strong preclinical activity and tolerability, supporting its potential to introduce a novel therapeutic approach in aggressive ...
5.
cancernetwork.com
cancernetwork.com/view/fda-grants-fast-track-designation-to-mt-125-in-glioblastomaFDA Grants Fast Track Designation to MT-125 in ...
The evaluation of MT-125's safety and preliminary activity in glioblastoma is underway in a phase 1/2 trial.
A Phase 1/2 Study of the Safety and Tolerability of MT-125 ...
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with ...
A Phase 1/2 Study of the Safety and Tolerability of MT-125 ...
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been ...
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