The trial will evaluate select patients exhibiting genetic alterations in the tyrosine kinase signaling pathways, RET, DDR and Trk, which are known oncogenic drivers.
The study will also explore other mechanisms that may play a role in regulating tumor growth, including selecting for patients with CBL mutations and chromosome 4 amplicon alterations.
"As we continue to better understand and pinpoint genetic alterations driving different types of cancer, we are able to more effectively identify patients who may benefit from specific molecularly-targeted therapies," said Todd Bauer, M.D., associate director of drug development and physician lead of personalized medicine, Sarah Cannon Research Institute.
"Results from the dose escalation phase in unselected patients indicate that MGCD516 is tolerable and we look forward to continuing this study with patients selected by specific genetic driver mutations to help advance treatment options."
Mirati president and CEO Charles Baum said: "We have identified the dose that achieved serum levels associated with tumor regressions in preclinical models and, we believe, will fully inhibit the genetic alterations that MGCD516 targets.
"By selecting and treating cancer patients, whose tumors carry driver mutations, we could see proof of concept in 2016 and the data could support accelerated development."
The purpose of the Phase 1b open-label trial is to evaluate the safety and efficacy of 150 mg once-daily (QD) MGCD516, administered orally, in patients with the genetic driver alterations of interest, including RET fusions, DDR mutations, Trk fusions and Trk mutations, CBL mutations and CHR4q12 gene amplification.
The trial will enroll patients with NSCLC as well as patients with advanced solid tumors that carry the genetic alterations of interest.