Study on the Safety and Tolerability of MT-125 in Patients with Glioblastoma
Sponsor: Myosin Therapeutics Inc.
ClinicalTrials ID:NCT07185880
This clinical trial is testing a new treatment called MT-125 for patients with glioblastoma, a type of brain tumor. The study aims to find the best dose and understand the safety of MT-125 when used with standard radiotherapy.
Patient Parameters
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Program Overview
The study is designed to find out the safest and most effective dose of a new treatment called MT-125 for patients with glioblastoma, a type of brain tumor. Participants will receive MT-125 along with their regular radiotherapy to see if it helps improve treatment outcomes. This is the first time MT-125 is being tested in humans, so its effects are not yet known. Up to 36 adults with newly diagnosed glioblastoma will be part of this study. The treatment is considered investigational, meaning it is still being studied and is not yet approved for general use.
Description
MT-125 is a new treatment being tested for glioblastoma, a serious brain cancer. It works by targeting cancer cells in the brain to stop them from growing and spreading. The study will test different doses of MT-125 to find the highest dose that patients can tolerate without severe side effects. Participants will receive MT-125 along with their regular radiotherapy over a period of six weeks. The study will monitor the safety and effectiveness of MT-125, as well as how it interacts with the body. If successful, this could lead to new treatment options for glioblastoma patients who do not respond well to current therapies. The study will also explore how well patients respond to the treatment and how long they live without the cancer getting worse. If the initial doses are well-tolerated, the study may test higher doses to find the most effective treatment level.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Newly diagnosed with a specific type of glioblastoma.
- Good overall health with a performance status score of 0, 1, or 2.
- Meet specific blood test requirements, including:
- Hemoglobin level of at least 9.0 g/dL.
- Neutrophil count of at least 1500/mm3.
- Platelet count of at least 100,000/mm3.
- Liver and kidney function within specified limits.
- Heart function must be normal, with a QTc interval of 470 ms or less.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must provide written informed consent.
- Able to complete questionnaires with or without help.
- Willing to return for follow-up visits.
- On a stable dose of steroids for at least two weeks before joining the study.
Exclusion Criteria
- Pregnant or nursing women, or those who can become pregnant and are not using effective birth control.
- Serious health conditions that could interfere with the study.
- Currently taking other investigational drugs.
- Any condition that could affect the study or pose a risk to the participant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital | 85054 | Phoenix | Arizona |
| Mayo Clinic Hospital | 32224 | Jacksonville | Florida |
| Mayo Clinic Hospital | 55905 | Rochester | Minnesota |
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