Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lifirafenib · 1 trial · 1 indication
Incidence and severity of AEs and SAEs and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
| Arm | Type | Description |
|---|---|---|
| Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens. | EXPERIMENTAL | Combination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day |
| Part B: Expansion | EXPERIMENTAL | Approximately 20 participants with NRAS mutated solid tumors will be enrolled |
| Name | Type | Description |
|---|---|---|
| Lifirafenib | DRUG | RAF Dimer Inhibitor |
| mirdametinib | DRUG | MEK Inhibitor |
Key Inclusion Criteria: 1. Able to provide informed consent 2. Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place 3. Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or c...
Lifirafenib is an investigational small molecule being studied for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated for its safety and pharmacokinetics in patients with advanced or refractory solid tumors.
Lifirafenib is being developed by BeOne Medicines Ltd., a biopharmaceutical company traded under the ticker symbol ONC. The company is conducting clinical research to evaluate the drug's potential in oncology, specifically for adult patients with solid tumors.
Lifirafenib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for the treatment of solid tumors in adults.
Lifirafenib has been studied in one clinical trial, registered as NCT03905148. This Phase 1 study evaluated the safety and pharmacokinetics of Lifirafenib in combination with PD-0325901 (Mirdametinib) in participants with advanced or refractory solid tumors. The trial enrolled 91 participants and was conducted in the United States and Australia.
Yes, Lifirafenib is also known as BGB-283. In clinical trial NCT03905148, the drug is referred to as BGB-283 (Lifirafenib). This alternative name may appear in scientific literature and trial registrations, but both names refer to the same investigational drug being developed by BeOne Medicines Ltd.