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Also known as BGB-283
Lifirafenib · 3 trials · 2 indications
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 |
| Stage I | EXPERIMENTAL | Approximately 25-35 Chinese subjects with local advanced or metastatic malignant solid tumor will be enrolled in the dose escalation stage of BGB-283 until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination |
| Stage II | EXPERIMENTAL | Approximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283 |
| Stage III | EXPERIMENTAL | 20 subjects will be enrolled for food effect stage of BGB-283 |
| BGB-283 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lifirafenib | DRUG | RAF Dimer Inhibitor |
| mirdametinib | DRUG | MEK Inhibitor |
| BGB-283 | DRUG | - |
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 developed by BeOne Medicines Ltd. for the treatment of advanced or refractory solid tumors in adults. It is a BRAF inhibitor that has been studied in a Phase 1 clinical trial. It is not approved and remains in clinical development.
Lifirafenib targets BRAF, a kinase in the MAPK signaling pathway. It acts as an inhibitor of BRAF. The Phase 1 study of lifirafenib was conducted in biomarker-selected participants with advanced or refractory solid tumors, evaluating the drug both alone and in combination with mirdametinib.
Lifirafenib is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company sponsored the Phase 1 study of the drug in participants with advanced or refractory solid tumors.
Lifirafenib is in Phase 1 development. Its only recorded clinical trial, NCT03905148, was a Phase 1 study that has been completed. The drug is investigational and has not been approved for any indication.
Lifirafenib has been evaluated in one clinical trial, NCT03905148, titled a study of the safety and pharmacokinetics of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) in participants with advanced or refractory solid tumors. The Phase 1 trial enrolled 91 participants across the United States and Australia and is completed.
Yes, lifirafenib is also known as BGB-283. Both names refer to the same investigational BRAF inhibitor developed by BeOne Medicines Ltd. The Phase 1 trial NCT03905148 lists the drug under the BGB-283 name.