Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

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.

Conditions

• Urothelial Carcinoma
• Renal Cell Carcinoma
• Non-Small Cell Lung Cancer
• Castration-resistant Prostate Cancer
• Triple Negative Breast Cancer
• Ovarian Cancer
• Endometrial Cancer
• Hepatocellular Carcinoma
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Colorectal Cancer
• Head and Neck Cancer
• Differentiated Thyroid Cancer
• Lower Esophageal Cancer

Interventions

DRUG

cabozantinib

Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.

DRUG

atezolizumab

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

DRUG

cabozantinib

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

DRUG

cabozantinib

Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd

Sponsors & Collaborators

• Exelixis

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-05

Primary Completion

2023-02-21

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• France
• Germany
• Italy
• Netherlands
• Spain
• United Kingdom

Study Locations