A Phase 1/2 Single-Arm Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of MT-125 Monotherapy With Radiation in Newly Diagnosed Glioblastoma
Myosin Therapeutics Inc.
Summary
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.
Description
MT-125 is a potent, selective, and central nervous system (CNS) permeable dual small molecule inhibitor of the non-muscle myosin II (NMII) paralogs, IIA and IIB. MT-125 is being developed by Myosin Therapeutics Inc. as a potential treatment for glioblastoma (GBM). NMIIs are molecular motor ATPases that act directly on actin to regulate the cytoskeleton's control of cellular processes such as movement, division, signaling and mitochondrial biology. As a result, simultaneous inhibition of NMIIA and IIB with MT-125 interferes with tumor cell proliferation, invasion and metastasis, while also gene…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years at the time of signing the informed consent form (ICF). 2. New Diagnosed with histologically or molecularly confirmed IDH wild type and MGMT unmethylated GBM. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2. 4. The following laboratory values obtained ≤15 days prior to registration: 1. Hemoglobin ≥9.0 g/dL 2. Absolute neutrophil count (ANC) ≥1500/mm3 3. Platelet count ≥100,000/mm3 4. Total bilirubin ≤1.5 x upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN (…
Interventions
- DrugMT-125
This is an investigational new drug under IND 170975.
Locations (3)
- Mayo Clinic HospitalPhoenix, Arizona
- Mayo Clinic HospitalJacksonville, Florida
- Mayo Clinic HospitalRochester, Minnesota