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Also known as Lifirafenib
BGB-283 · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-283 is an investigational small molecule being studied for the treatment of solid tumors, including locally advanced or metastatic malignant solid tumors. It is in Phase 1 clinical development and is not approved for any indication. All trials of BGB-283 to date have been conducted in adult patients with solid tumors.
BGB-283 targets RAF, a kinase enzyme involved in cell signaling. By acting on RAF, BGB-283 is designed to interfere with signaling pathways that drive tumor growth. RAF is a well characterized kinase target in oncology drug development, and BGB-283 is a small molecule inhibitor directed at it.
BGB-283 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company has sponsored the clinical trials of BGB-283 conducted to date. BeOne Medicines is the sole developer named for this asset.
BGB-283 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. Both of its completed trials were Phase 1 studies, and no later-phase trials have been initiated.
BGB-283 has been evaluated in two completed Phase 1 trials. NCT02610361 studied safety and pharmacokinetics in patients with solid tumors in Australia and New Zealand, enrolling 131 patients. NCT03641586 studied BGB-283 in Chinese subjects with locally advanced or metastatic malignant solid tumors, enrolling 42 patients.
A total of 173 patients have been enrolled across the two completed Phase 1 trials of BGB-283. NCT02610361 enrolled 131 patients and NCT03641586 enrolled 42 patients. Both studies were controlled, non-randomized, open-label Phase 1 trials in adults with solid tumors.