Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MT-125 · 1 trial · 1 indication
The dose escalation portion of this study will follow a BOIN design with cohorts containing a min of 3 DLT evaluable participants. If the observed DLT rate at the current dose is ≤0.236, then the decision will be to escalate the dose to the next higher dose level; if the observed DLT rate at the current dose is \>0.359, then the decision will be to deescalate the dose to the next lower dose level; otherwise, the decision will be to stay at the current dose level.
Incidence and Severity, attribution, grade and type of AE will be assessed based on the NCI CTCAE v5.
| Arm | Type | Description |
|---|---|---|
| MT-125 at 25 mg | EXPERIMENTAL | 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 |
| MT-125 at 50 mg | EXPERIMENTAL | 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 |
| MT-125 at 83.5 mg | EXPERIMENTAL | 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 |
| MT-125 at 100 mg | EXPERIMENTAL | 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 |
| MT-125 at MTD and one dose lower than MTD | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| MT-125 | DRUG | This is an investigational new drug under IND 170975. |
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 wildtype and MGMT methylated GBM. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.. 4. The following laborato...
MT-125 is an investigational small molecule being developed for the treatment of glioblastoma, specifically for patients with newly diagnosed MGMT methylated glioblastoma. It is being studied in combination with chemoradiation. The drug is currently in Phase 1 clinical development.
MT-125 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The company is conducting clinical trials of MT-125 in the United States for the treatment of glioblastoma.
MT-125 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1/2 study of MT-125 is planned but has not yet started recruiting participants.
MT-125 is being studied in a Phase 1/2 clinical trial with the identifier NCT07604285. This trial is titled 'A Phase 1/2 Study of Safety and Tolerability of MT-125 With Chemoradiation in Patients With Newly Diagnosed MGMT Methylated Glioblastoma' and is expected to enroll 36 participants in the United States.
No, the clinical trial of MT-125 is not randomized. It is a controlled study, but it is not double-blinded. The trial is designed to evaluate the safety and tolerability of MT-125 when combined with chemoradiation in patients with newly diagnosed MGMT methylated glioblastoma.
Yes, the MT-125 clinical trial uses a biomarker for patient selection. The study enrolls patients with MGMT methylated glioblastoma, meaning the MGMT promoter methylation status is used as a biomarker to identify eligible participants.