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) 1.4
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
1802 6th Ave. South
Birmingham
AL
35294
USA
1365C Clifton Road
Atlanta
GA
30322
USA
Iowa City
IA
52242
USA
55 Fruit Street
Boston
MA
02114
USA
New York
NY
10032
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
2000 Circle of Hope
Salt Lake City
UT
84103
USA
Madison
WI
53792
USA