Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary
efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in
subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including
bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant
prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer
(TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric
cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal
cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study
consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib
dose for the combination with standard dosing regimen of atezolizumab will be established; in
the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the
safety and efficacy of the combination treatment in these tumor indications. Three
exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or
CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled
with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive
combination treatment with both cabozantinib and atezolizumab after they experience
radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of
this study design, some tumor cohorts may complete enrollment earlier than others.