CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2021-07-16
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calithera Biosciences, Inc

Criteria

Inclusion Criteria:

1. Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component

2. Adult patients

3. Karnofsky Performance Score (KPS) ≥ 70%

4. Measurable Disease per RECIST 1.1

5. 1-2 lines of prior therapy for advanced or metastatic RCC including one anti-angiogenic therapy (any VEGF pathway-targeted agent used either as monotherapy or as a component of a combination regimen) OR the combination regimen of nivolumab + ipilimumab

6. Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

1. Prior treatment with cabozantinib (or other MET inhibitor) or CB-839

2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment

3. Untreated or active brain metastases or central nervous system cancer, as defined per protocol

4. Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug

5. Known active infection with HIV, Hepatitis B or C virus

6. Inability to discontinue proton-pump-inhibitor use before randomization

7. Patients who are pregnant or lactating