Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMF-500 · 1 trial · 1 indication
Assessed by the NCI CTCAE version 5.0.
Assessed by the NCI CTCAE version 5.0.
Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.
| Arm | Type | Description |
|---|---|---|
| Arm A: Escalation Phase | EXPERIMENTAL | BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity. |
| Arm B: Escalation Phase | EXPERIMENTAL | BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors. |
| Arm C: Escalation Phase | EXPERIMENTAL | BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors. |
| Name | Type | Description |
|---|---|---|
| BMF-500 | DRUG | Investigational Product |
Key Inclusion Criteria: * Age ≥ 18 years. * Individuals with histologically or pathologically confirmed diagnosis of relapsed or refractory AML with documented FLT3 mutation, and/or Individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type FLT3 (includ...
BMF-500 is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in adult patients with acute leukemia.
BMF-500 targets FLT3, a gene that is frequently mutated in Acute Myeloid Leukemia. By targeting FLT3, the drug aims to interfere with the signaling pathways that drive the growth of leukemia cells. This mechanism is being evaluated in early-stage clinical trials.
BMF-500 is being developed by Biomea Fusion, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol BMEA. Biomea Fusion is conducting clinical trials to evaluate the safety and efficacy of BMF-500 in patients with acute leukemia.
BMF-500 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of BMF-500 in adults with acute leukemia.
BMF-500 is being studied in a Phase 1 clinical trial with the identifier NCT05918692. The trial, titled 'A Phase 1 Study of BMF-500 in Adults With Acute Leukemia,' is active but not recruiting participants. It is enrolling approximately 35 patients in the United States.
No, BMF-500 is a unique investigational compound developed by Biomea Fusion. It is not known to have any alternative names. The drug is being studied specifically for its potential role in treating Acute Myeloid Leukemia and is in early-stage clinical development.