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

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in
combination with cabozantinib versus placebo with cabozantinib in Renal Cell Carcinoma
patients with at least one and not more than 2 prior therapies in the advanced or metastatic
setting.

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