Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Solid Tumors

Active, not recruiting

1

Start Date 02/01/2014

Age of Trial (yrs) 10.2

Gleevec-resistant

SDH-directed

Block related tumor signal paths

Specifically GIST plus other cancers

CX-839-001

Calithera Biosciences, Inc

clinicaltrials@calithera.com

Oral

Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will be enrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.