Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID07185880

A Phase 1/2 Study of MT-125 Monotherapy With Radiation to Assess Safety, Tolerability, and Pharmacokinetics in Newly Diagnosed Glioblastoma

Led by Myosin Therapeutics Inc. · Updated on 2026-04-14

36

Participants Needed

3

Research Sites

274 weeks

Total Duration

On this page

Sponsors

M

Myosin Therapeutics Inc.

Lead Sponsor

M

Mayo Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and dosing of a new investigational drug called MT-125 in adults newly diagnosed with glioblastoma, a primary brain tumor. MT-125 targets specific proteins involved in tumor cell growth and is being studied in combination with standard radiotherapy. The study focuses on patients with a particular tumor type (IDH wild type, MGMT unmethylated) who typically do not respond well to current therapies, addressing an urgent need for new treatment options. Participants will receive MT-125 alongside their radiotherapy. The study begins with a dose escalation phase where small groups receive increasing doses of MT-125 for 5 days a week with 2 days off over 6 weeks, to find the highest dose that can be safely tolerated. After establishing this dose, additional participants will be randomly assigned to receive either the highest dose or one dose level lower, also combined with radiotherapy, to further assess safety and preliminary responses. During the study, participants will be monitored closely for any side effects and dose-limiting toxicities over the 6-week treatment period. Researchers will measure drug levels in the blood at several time points and assess overall safety, tolerability, and preliminary efficacy. Participants will complete questionnaires and have regular laboratory tests, heart function assessments, and pregnancy tests as applicable. The total participation time includes the 6 weeks of treatment with follow-up monitoring to ensure safety and collect data on response and survival outcomes.

CONDITIONS

Brief Title

A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of consent
  • Newly diagnosed with histologically or molecularly confirmed IDH wild type and MGMT unmethylated glioblastoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Laboratory values within specified normal ranges: hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1500/mm3, platelet count ≥100,000/mm3, total bilirubin ≤1.5 times upper limit of normal, ALT and AST ≤3 times upper limit of normal (or ≤5 times if liver involvement), PT/INR/aPTT ≤1.5 times upper limit of normal or within therapeutic range if on anticoagulants, serum eGFR ≥60 ml/min
  • QTc interval ≤470 ms on triplicate 12-lead ECG
  • Left Ventricular Ejection Fraction (LVEF) ≥55% by echocardiography
  • Negative serum pregnancy test within 7 days before first dose for persons of childbearing potential
  • Ability to provide written informed consent
  • Ability to complete questionnaires independently or with assistance
  • Willingness to return for follow-up visits during active monitoring
  • Stable steroid dose for at least 2 weeks prior to enrollment
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons
  • Persons of childbearing potential and persons able to father a child unwilling to use adequate contraception
  • Presence of co-morbid systemic illnesses or severe concurrent diseases that may interfere with safety assessment
  • Receiving any other investigational agents
  • Any disease, condition, or treatment that poses unacceptable risk or interferes with study conduct or data interpretation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive MT-125 monotherapy combined with radiation therapy for their newly diagnosed glioblastoma. MT-125 is administered 5 consecutive days per week with 2 days off for a total of 6 weeks of outpatient treatment.

Weekly visits for up to 6 weeks

Trial Site Locations

Total: 3 locations

1

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Mayo Clinic Hospital

Jacksonville, Florida, United States, 32224

Actively Recruiting

3

Mayo Clinic Hospital

Rochester, Minnesota, United States, 55905

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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Published Research Related To This Trial

Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group.

Patrick Y Wen, David R Macdonald, David A Reardon...

https://pubmed.ncbi.nlm.nih.gov/20231676

MGMT Promoter Methylation Cutoff with Safety Margin for Selecting Glioblastoma Patients into Trials Omitting Temozolomide: A Pooled Analysis of Four Clinical Trials.

Monika E Hegi, Els Genbrugge, Thierry Gorlia...

https://pubmed.ncbi.nlm.nih.gov/30514777