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A First-in-Human, Phase 1a/1b, Open Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dimer Inhibitor BGB-3245 in Patients With Advanced or Refractory Tumors
This is a non-randomised dose escalation and dose expansion study assessing BGB-3245 in people with tumours harbouring B-RAF mutations that are likely to respond to a RAF dimer inhibitor. Phase 1a will consist of a dose-escalation and dose finding component to establish the MTD and/or RP2D in participants with MAPK pathway aberrations. In this, phase participants will receive BGB-3245 (orally) as a continuous daily administration, in 28 day and 30 day cycles. Phase 1b will consist of a dose expansion component and is split into two groups. Phase 1b, Group 1 is focusing on dose expansion in non-V600 B-RAF mutations. BGB3245 will be administered (orally) as a continuous daily administration, in 28 day and 30 day cycles in participants with non-V600 B-RAF including RAF fusions. Phase 1b, Group 2, is focus on dose expansion in B-RAF V600 mutations. BGB-3245 will be administered (orally) as a continuous daily administration, in 28 day and 30 day cycles in participants with B-RAF V600mutatted melanoma or NSCLC B-RAF and/or MEK inhibitor resistant tumours (i.e. have progressed on a B-RAF-inhibitor and/or MEK-inhibitor).