A Phase 1/2 Study of Safety and Tolerability of MT-125 With Chemoradiation in Patients With Newly Diagnosed MGMT Methylated Glioblastoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Myosin Therapeutics Inc.
Study ID
NCT07604285
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

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).

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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 for 2 days for a total of 6 weeks in combination of RT plus TMZ
  • Experimental: MT-125 at 50 mg
    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
  • Experimental: MT-125 at 83.5 mg
    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
  • Experimental: MT-125 at 100 mg
    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
  • 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 RT plus TMZ

Primary Outcome Measure

Dose Limiting Toxicity Measurement [ Time Frame: 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
Ugur Sener, MD (PRINCIPAL_INVESTIGATOR)

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