TRIAL DETAIL

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

Drug:
Trial Name:
Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors
NCT#:
Conditions:
Solid Tumors
Status:
Recruiting
Phase:
1/2
Start Date 03/01/2019
Age of Trial (yrs) .6
Treatment Phase:
Gleevec-resistant
Drug Category:
SDH-directed
Strategy:
Inhibit Glycolysis and inhibit DNA DSB repair
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
CX-839-011
Sponsor:
Calithera Biosciences, Inc
Patient Contact:
Clinical Administrator 650-870-1000 clinicaltrials@calithera.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
4319 Medical Dr.
San Antonio
TX
78229
USA