Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors

Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors

Solid Tumors

Terminated

1/2

Start Date 03/01/2019

Age of Trial (yrs) 5.2

Gleevec-resistant

SDH-directed

Inhibit Glycolysis and inhibit DNA DSB repair

GIST not specified. GIST patient enrollment unknown.

CX-839-011

Calithera Biosciences, Inc

Clinical Administrator 650-870-1000 clinicaltrials@calithera.com

Oral

Brief Summary:
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the PARP inhibitor talazoparib in participants with advanced/metastatic solid tumors.

Detailed Description:

This is a multicenter, open-label, dose-escalation and dose-expansion study. In Part 1, escalating doses of CB-839 will be paired with the standard dose of talazoparib in order to determine the maximum tolerated dose (MTD) and/or the RP2D of the regimen and to characterize the safety and tolerability profile of the combination in participants with advanced/metastatic solid tumors.

In Part 2, the combination of CB-839 and talazoparib will be evaluated at the RP2D determined in Part 1 to evaluate the anti-cancer activity of the regimen in participants with advanced/metastatic clear cell RCC, TNBC or CRC.