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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Myosin Therapeutics Inc.
Study ID
NCT07185880
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MT-125 — DRUG
    This is an investigational new drug under IND 170975.

Study Details

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 glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment. Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose. Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to destroy them. It will be administered on the same day as your standard of care radiotherapy because it is also designed to help radiotherapy work better. However, this is the first time MT-125 will be studied in humans. Therefore, the use is considered investigational. If you would like more details about MT-125 in glioblastoma participants, please ask the Study Doctor. You will be among the first participants with glioblastoma to receive this study treatment. Its safety and effectiveness have not yet been established in humans. Thus, we do not know whether it will work for you. Your condition may improve, may get worse, or there may be no change. The selected participant population-individuals newly diagnosed with histologically and/or molecularly confirmed IDH wild-type, MGMT-unmethylated glioblastoma-represents those least likely to experience safety concerns or adverse events related to the study treatment, and most likely to derive therapeutic benefit. There are certain tests/questions you must complete to find out if you meet the requirements to be in the study. If you do not meet these requirements, you cannot take part in the study. If this happens, you can talk to your Study Doctor about other options.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Feb 29, 2032

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MT-125 at 25 mg
    Up to 6 participants will receive 25 mg of MT-125 for 5 days, then off 2 days for a total of 6 weeks in combination with radiation therapy.
  • Experimental: MT-125 at 50 mg
    Up to 6 participants will receive 50 mg of MT-125 for 5 days, then off 2 days for a total of 6 weeks in combination with radiation therapy.
  • Experimental: MT-125 at 83.5mg
    Up to 6 participants will receive 83.5 mg of MT-125 for 5 days, then off 2 days for a total of 6 weeks in combination with radiation therapy.
  • Experimental: MT-125 at 100 mg
    Up to 6 participants will receive 100 mg of MT-125 for 5 days, then off 2 days for a total of 6 weeks in combination with radiation therapy.
  • Experimental: MT-125 at MTD and one dose lower than MTD
    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 radiation therapy.

Primary Outcome Measure

Dose Limiting Toxicity Measurement [ Time Frame: From Day 1 through 6 weeks of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054
Clinical Trials Referral Office
[email protected]
855-776-0015
Shannon F Fortin-Ensign, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic HospitalJacksonvilleFlorida32224
Clinical Trials Referral Office
[email protected]
855-776-0015
Wendy J Sherman, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic HospitalRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
[email protected]
Ugur Sener, MD (PRINCIPAL_INVESTIGATOR)

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