Phase I, Open-Label, Dose-Escalation/Dose-Expansion Study of Lifirafenib (BGB-283), an RAF Family Kinase Inhibitor, in Patients With Solid Tumors.

ABSTRACT:

Purpose

Lifirafenib is an investigational, reversible inhibitor of B-RAF^V600E, wild-type A-RAF, B-RAF, C-RAF, and EGFR. This first-in-human, phase I, dose-escalation/dose-expansion study evaluated the safety, tolerability, and efficacy of lifirafenib in patients with B-RAF- or K-RAS/N-RAS-mutated solid tumors.

Methods

During dose escalation, adult patients with histologically/cytologically confirmed advanced solid tumors received escalating doses of lifirafenib. Primary end points were safety/tolerability during dose escalation and objective response rate in preselected patients with B-RAF and K-RAS/N-RAS mutations during dose expansion.

Results

The maximum tolerated dose was established as 40 mg/d; dose-limiting toxicities inclu

SUBMITTER: Desai J 

PROVIDER: S-EPMC7325368 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature