Oncology firm BeiGene has enrolled the first patient in its Phase Ib clinical trial of BGB-283, a second generation B-RAF inhibitor with unique RAF dimer and EGFR inhibiting activity.
BGB-283 demonstrated better anti-tumour activities in preclinical models for cancers with B-RAF V600E mutation, in addition to the non-V600E B-RAF mutation and K-RAS/N-RAS mutations.
The company has designed the study to assess the efficacy of a once daily oral dosing regimen for BGB-283 in solid tumours that harbour B-RAF mutations or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.
The Phase Ib trial is being carried out across multiple centres in Australia and New Zealand.
BeiGene CEO John Oyler said: "BGB-283 is a clinically differentiated B-RAF inhibitor able to hit multiple important mutations in the RAS-MAPK pathway.
"The data from the Phase Ia dose escalation study gave us confidence to move into a broad Phase Ib study that is designed to demonstrate BGB-283’s single agent activity across a wide range of solid tumours."
BeiGene has started the Phase Ib study following the successful completion of a Phase Ia dose escalation study in patients who have B-RAF or K-RAS mutations.
In the Phase Ia trail, BGB-283 showed a better safety profile along with promising early clinical activity in patients harbouring mutations that previously could not be targeted by first generation B-RAF inhibitors, said BeiGene.
First generation B-RAF inhibitors such as vemurafenib and dabrafenib selectively target mutant B-RAFV600E and have exhibited enhanced clinical activities in melanoma patients with the B-RAFV600E mutation.
These inhibitors received approval to treat patients with B-RAFV600E metastatic melanoma.