NCT03965845

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

A Phase 1b/2, Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With CDK4/6 Inhibitor Palbociclib in Patients With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors.

Conditions

• Solid Tumors
• NSCLC
• CRC
• KRAS Gene Mutation

Interventions

Type	Name	Description
DRUG	Telaglenestat (CB-839)	Teleglenastat is an oral tablet administered twice daily with food at the assigned dose level. Dose is taken with palbociclib each day in 28-day cycles.
DRUG	Palbociclib Oral Capsule or Tablet [Ibrance]	Palbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat. Days 22-28 of every cycle, palbociclib is not taken.

Timeline

• Start date: 2019-06-25
• Primary completion: 2021-09-24
• Completion: 2021-09-24
• First posted: 2019-05-29
• Last updated: 2022-09-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study