RENAL: METASTATIC: 2nd Line or later: CANTATA

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA

Title
Calithera CX-839-008 (Renal)
Study Title

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA

Site Link
Malignancy
Renal Cell Carcinoma, Kidney Cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd or 3rd line
Investigational Agent
CB-839
Drug Class
oral glutaminase inhibitor
PI
Dan Vaena, MD
Sponsor
Calithera Biosciences
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic renal cell carcinoma with a clear cell component
  • Karnofsky PS 70% or higher
  • 1-2 lines of prior therapy for advanced or metastaic RCC including at least one antiangiogenic therapy or nivolumab+ipilimumab
  • No prior treatment with cabozantinib or other MET inhibitor
  • No active CNS malignancies
  • No known HIV, HBV, HCV
  • No need for Proton -pump inhibitors
Objective

Primary- PFS; Secondary- OS, PFS by investigator assessment

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Clear cell component
Dosing Frequency
Control Agents
placebo plus cabozantinib
Study Protocol
Randomized
Yes
X